- LOGIN
- MemberShip
- 2026-05-18 18:21:05
- Company
- Alunbrig proves the effectiveness of epilepsy patients
- by Sep 09, 2021 05:54am
- Competition is fierce for the first standard treatment as the second and third generation drugs, which are next-generation drugs, appear one after another in the ALK-positive non-small cell lung cancer treatment market. Target anticancer drugs targeting ALK mutations include the first generation Xalkori (Crizotinib), the second generation Zykadia (Ceritinib), "Alecensa (Alectinib HCl), and the third generation Lorviqua (Lorlatinib). A generational shift is taking place in Xalkori, which has long been the first standard treatment. Except for Lorviqua, which still has only secondary treatment indications, Roche's Alecensa and Takeda's Alunbrig are the most fiercely competitive drugs in Korea. Both are second-generation drugs and are similar, showing excellent effects on patients with brain metastasis. Alunbrig, which was released relatively late, has different convenience and tolerability from Alecensa. Dr. Ross Camidge ( University of Colorado Cancer Center), who participated in the Alunbrig online media session held by Takeda Pharmaceutical Korea on the 3rd, showed similar results that he was superior to Xalkori through phase 3 clinical trials of Alunbrig and Alecensa. This is also the case in patients with epilepsy, he said. The secondary factors Dr. Ross Camidge refers to convenience, safety, tolerability, and cost. In this respect, he said Alunbrig is a good drug to choose from as the primary treatment. Looking at the convenience, Alcensa needs to be taken 8 capsules a day and Alunbrig needs to be taken only once a day (two tablets a day in some countries). In terms of quality of life, Alunbrig maintains a high quality of life for a long time. Dr. Ross Camidge explained, "In Alunbrig clinical trials, the time point at which the Crizotinib group recorded a lower quality of life than Alunbrig was faster than expected." Early-Onset Pulmonary Events (EOPE) were also concluded to improve when the drug was stopped for a while and then taken again. Referring to this, Dr. Ross Camidge added, "If you are worried about lung abnormalities, you will not take 90mg for seven days from the beginning, but 30, 60, and 90mg for three days each, and the method of slowly increasing will be effective." Lorviqua, a third-generation drug, was diagnosed with great side effects. He said, "The PFS risk ratio of Lorviqua's phase 3 CROWN study shows the best number among existing treatments," but added, "However, there are significant side effects, with about 80% of patients taking additional drugs with cholesterol levels, and half suffer from central nervous system functional problems. Even when looking at the quality of life data, the quality of life deterioration patterns of Lorlatinib and the control group (Crizotinib) overlap considerably, he said. For this reason, controversy still persists over whether Lorviqua should be viewed as a primary treatment option. Dr. Ross Camidge said, "Personally, Lorviqua is better to be used in secondary or higher treatment situations," adding, "In particular, ALK-positive lung cancer means that there is no need to use highly toxic drugs from the beginning of treatment." He said, "If we have to use Lorlatinib as a secondary drug like Korea, we will choose Alunbrig, which has better convenience and resistance, rather than Alecensa, as the primary treatment."
- Company
- It would have been a big trouble if no improvement
- by Chon, Seung-Hyun Sep 08, 2021 06:07am
- Pharmaceutical companies are actively working on transferring drug copyrights. As drug prices of transfer and transfer drugs are allowed, the transfer of permission rights due to mergers and acquisitions or corporate separation is speeding up. It is trying to enter the new generic market by receiving expensive products from other companies. According to the MOHW on the 7th, Celltrion's Actos 15mg will be newly listed on the health insurance benefit list at 626 won starting this month. The copyright of Actos 15mg will be changed to Celltrionl. Takeda Korea's Actos 15mg was removed from the list. It is a follow-up measure to Celltrion's acquisition of Takeda's drugs. Celltrion acquired Takeda's primary care division in the Asia-Pacific region for $278 million in June last year. Takeda has all rights to patents, trademarks, and sales of 18 pharmaceutical products sold in Korea, Thailand, Taiwan, Hong Kong, Macau, the Philippines, Singapore, Malaysia, and Australia. In Korea, Celltrion will take over the rights of Takeda products acquired by Celltrion. Celltrion is in the stage of completing the transfer of rights in Korea through the procedure of changing permission rights and registering drugs. The price of Actos 15mg remains the same as the previous drug price of 626 won. The previous upper limit of 626 won was maintained as the drug price succession rule was newly established in January. If the right to Actos 15mg was changed last year, drug prices are likely to have fallen significantly. Due to the reorganization of the drug price system in July last year, the drug price system was implemented, where the drug price fell as the registration time was delayed. If there are more than 20 identical registered products, generic will have a 15% lower drug price. At this time, the transfer drug was listed at the lowest price among the same products due to the application of the step-type drug price system. If the drug license is changed, it goes through a procedure of deleting and re-registration. Even if it was a previously registered product, it was inevitable to apply a step-type drug price system. When the pharmaceutical industry pointed out that it was unfair to register transferred drugs in the same way as newly registered products, the MOHW accepted the improvement of the system improvement. With the revision of the regulations, Actos was able to maintain the previous drug price of 626 won. Singulair Chewable 4mg of Organon Korea has been listed at 693 won since this month. As the license was changed to Organon, a new corporation spun off from MSD Korea, it was newly listed on the health insurance benefit list. The 4mg Singular Chewable has 59 identical products listed. If 4mg of Singular Chewable is recognized as a newly registered product, it cannot exceed 322 won. As drug prices were allowed to succeed, drug prices avoided falling below half. Organon's Vytorin 10/10 and Vytorin 10/20 were listed at 782 won and 1,093 won, respectively. Vytorin 10/10 and Vytorin 10/20 each have 48 generics listed, so new licensed products are subject to the step-type drug price system. If Vytorin 10/10 is applied as a newly registered product, it cannot exceed 481 won. However, due to the improvement of the system, the previous drug price was applied as it was.
- Opinion
- Clear standards needed for direct purchase of drugs overseas
- by Kim JiEun Sep 08, 2021 06:06am
- The world’s leading online e-commerce platform Amazon joined forces with one of the top e-commerce companies in Korea to set foot into the Korean market. The entry of this global direct purchasing giant into Korea had raised industry concerns that it would increase the illegal direct purchase of pharmaceuticals overseas and void the government’s efforts to eradicate the expanding market for such items. Aware of such concerns, 11street had prepared a separate guide on ‘precautions for direct purchase of drugs and health functional foods overseas’ to its Amazon store website and blocked the transaction of pharmaceuticals and health functional foods that contain ingredients that are not permitted in Korea. While answering that they feel partially reassured by such measures, pharmacists stressed that a more fundamental standard and measures are necessary to regulate online transactions of pharmaceuticals at a time when the direct purchase of goods overseas is being established as a culture in the midst of the rise of the e-commerce. The Pharmaceutical Affairs Act in Korea completely prohibits the sale of pharmaceuticals online. However, the Customs Act recognizes overseas transactions of pharmaceuticals as legal to a limited extent, leading to a conflict between the two Acts. In addition, the standards for overseas transactions stipulated in the Customs Act are obscure. The law stipulates that up to 3 months' worth or 6 bottles of OTCs that do not contain specific products or ingredients may be brought into the country for self-use, which leaves much room for interpretation. Some pharmaceuticals contain 100 tablets or even 1,000 tablets per bottle. The ‘Pharmacists’ Community for Future Pharmacy’ pointed out that the customs regulations mentioned above are unclear and meaningless, as a consumer may abuse the regulation and purchase up to 6,000 tablets at most to bring into the country. The illegal direct purchase of pharmaceuticals overseas had been carried out openly in many e-commerce open markets in Korea. Leading e-commerce platforms in Korea have allowed transactions of pharmaceuticals through direct purchase from overseas, including many unauthorized drugs as well as prescription drugs that should not be traded between individuals. Times have changed. E-commerce has taken over the offline retail market, and the market for direct purchases from overseas is also growing at a rapid pace. With the growth, the direct purchase of illegal pharmaceuticals has also increased explosively. This is why the government can no longer hold back revising the related laws while weighing the different perspectives held by the ministries.
- Policy
- Proposal of a bill to abolish special cases for Jeju
- by Lee, Jeong-Hwan Sep 08, 2021 06:05am
- A bill has been proposed by the National Assembly to abolish special cases for the opening of Jeju for-profit hospitals. The move is aimed at resolving the controversy over the establishment of for-profit hospitals by deleting special cases for opening foreign medical institutions. On the 7th, Representative Wi Sung-gon of Democratic Party of Korea (Seoguipo City) proposed an amendment to the Special Act on the Establishment of Jeju Special Self-Governing Province and the Creation of Jeju Free International City. The amendment is to abolish the special cases for the establishment of medical institutions stipulated in Articles 307 and 308 of the Special Act. With the permission of the provincial governor, the provisions for opening medical institutions established by foreigners will be abolished. The abolition of the provisions for opening foreign-only pharmacies and the abolition of special telemedicine for medical personnel working in foreign medical institutions were also included in the bill. Measures to strengthen the public health of Jeju Free International City were included in the bill. This is to strengthen the publicity of medical care, which is supposed to be established under Article 306 of the Special Act. It is mandatory to add projects linked to the Framework Act on National Health and Medical Service, major health and medical project plans and financing and management matters, and evaluation of the impact of residents' health on climate change. Rep. Wi Sung-gon explained, "We abolished the provisions for the establishment of Jeju for-profit Hospital, which had been in great social conflict due to controversy over the damage to the public nature of medical care, and started to improve the system on ways to expand public health at the local level." He said, "As the importance of public health care has grown even more in the COVID-19 era, we will do our best to ensure that this amendment is passed by the National Assembly."
- Policy
- 3 companies voluntarily recall varenicline products
- by Lee, Jeong-Hwan Sep 08, 2021 06:05am
- Results of the safety investigation conducted by the Ministry of Food and Drug Safety on the N-nitroso-varenicline (NNV) impurity that was found in the smoking-cessation aid varenicline showed that the impurity’s risk of harming the human body was very low. However, all drugs that contain over ‘733ng (nanograms)/day’ of NNV will be voluntarily recalled by the companies in line with the standards set by the U.S regulators, Varenicline products that will be voluntarily recalled include those manufactured (consigned products included) by CTC Bio, and consists of 2 lots of Zerocotine tab. from Vivozone, 2 lots of Nicobreak tab. from CTC Bio, and 15 lot of Nokotine S from Hanmi Pharmaceutical. The MFDS announced the results of the NNV safety investigation on the 7th. With NNV detected in all products currently distributed in Korea, the Ministry plans to conduct phased safety management measured to assess its effect on administered patients, set standards on the acceptable level of NNV intake, prepare measures for each amount of NNVs detected, and issue guidelines for HCPs and patients. According to the MFDS, the NNV detected in varenicline products distributed in Korea was very low (16.70~1849ng/day). More specifically, NNV detected in varenicline products that were sold in Korea were: 16.70~1849ng/day for Jeil Pharmaceuticals’ products, 151~632ng/day for Pfizer Korea’s, and 812~1859ng/day for CTC Bio’s products. Products from Jeil Pharmaceuticals and CTC Bio were manufactured in Korea (including consigned products), and Pfizer’s was imported. Assessment of NNV’s effect on the human body also showed a very low level of concern. The safety investigation results were conducted according to the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) standards, in consideration of the daily maximum dose of intake, NNV test results, the actual period of administration for patients who participated in the NHIS’s smoking cessation treatment support project. Assessment of NNV’s effect on the human body showed that the NNV brought further cancer risk to 0.194-0.391 out of 100,000 people. The ICH guideline defines the risk to be at a 'negligible level' if the probability is less than 1 in 100,000 people. In consideration of the toxicity value set for NTHP, another nitrosamine-class substance with a very similar structure to NNV, the MFDS set the acceptable amount of daily intake of NNV to 37ng/day. This is the same as the level set by regulation institutions abroad and was determined after consultation with the Central Pharmaceutical Affairs Council. The acceptable amount of daily intake is the amount that increases the probability of developing cancer by 1/100000 when a substance is taken for a lifetime (70 years), apart from the naturally occurring cancer. The MFDS decided to allow the lot release of varenicline products that contain NNV of 185ng/day or less for the time being. This is the same level of standards as the one that was temporarily set by the U.S. The MFDS decision was affected by the fact that the NNV detected in varenicline was at almost no health risk as found from the NNV human impact assessment, and that it is difficult to immediately reduce the NNV amount to less than the acceptable amount of daily intake (37ng/day). The MFDS comprehensively reviewed the US's temporary approval of the lot release at 185ng/day, accessibility to smoking cessation drugs for patients, and advice from the Central Pharmaceutical Affairs Council. In particular, all drugs that are currently in the market whose NNV content exceeds 733ng/day will be voluntarily recalled by the companies. This is in line with the decision made by the U.S. to distribute drugs that contain 733ng/day or less without recall. Accordingly, all lots of the 6 varenicline products from 3 companies that were manufactured by CTC Bio will be voluntarily recalled. The MFDS plans to continue working with the pharmaceutical industry so that the amount of NNV detected can be reduced below the acceptable amount of daily intake as quickly as possible, and will announce the results after the reductions are complete. In addition, the MFDS recommended that patients who have already been prescribed the said products (lot numbers) should not arbitrarily discontinue the use of the drug but consult with his/her doctor or pharmacist on continuing taking the drug or switching to a different medication. If a patient needs to switch to an alternative drug after consultation with his/her doctor or pharmacist, the patient will need to receive a prescription for the alternative smoking cessation treatment from a medical institution participating in the National Health Insurance Service’s smoking cessation treatment support project.
- Policy
- GSK's Shingrix has been granted
- by Lee, Tak-Sun Sep 08, 2021 06:05am
- GSK's shingles virus vaccine has been approved in Korea. As a result, competition between MSD and SK Bioscience is expected to take place for the lead in the market. The MFDS approved GSK's gene recombinant shingles vaccine Shingrix on the 6th. This product is a vaccine used to prevent shingles in adults over the age of 50 and those who are expected to have high risk of shingles due to disease or treatment or immunosuppressants. It is a product that injects 0.5ml IM once and twice every two months. Shingrix was approved by the U.S. FDA in October 2017. In the United States, it is recognized for its product power by beating its competitors and ranking first in market share within a year of its launch. The strong defense effect shown in clinical trials is emerging as market competitiveness. Shingrix demonstrated an ERA of 97.2% in a 3.2-year follow-up in clinical trials (ZOE-50) in adults over 50 years of age, and 89.8% in 3.7-year follow-up in 70 years of age (ZOE-70). Compared to the fact that MSD's Zostavax had a 51% ERA in patients over 50 years of age and 41% in patients over 70 years of age, Shingrix is very superior. Sky Zoster, developed by SK Bioscience, is a product that proves non-inferiority compared to Zostavax. With the launch of Shingrix, the domestic shingles vaccine market, divided by Zostavax and Sky Zoster, will inevitably be reorganized. As of last year's IQVIA, sales of Zostavax and Sky Zoster were 43.2 billion won and 29.1 billion won, respectively. However, sales of shingles vaccines are on the decline this year due to COVID-19 vaccination. When COVID-19 subsides, sales are expected to rebound again. The MFDS classified Shingrix as a new drug and designated it as a drug subject to reexamination (PMS) by September 5, 2027.
- Policy
- Roche’s Herceptin+Perjeta combo is approved in Korea
- by Lee, Tak-Sun Sep 07, 2021 05:53am
- Roche’s developed a fixed-dose combination using two of its breast cancer treatments, Herceptin (trastuzumab) and Perjeta (pertuzumab). The Ministry of Food and Drug Safety approved Roche Korea’s ‘Phesgo (trastuzumab/pertuzumab) on the 6th. Trastuzumab and pertuzumab are commonly used ingredients for breast cancer. The original brand name of trastuzumab is ‘Herceptin,’ a blockbuster drug that sold ₩69.9 billion last year according to IQVIA The original brand name of pertuzumab is ‘Perjeta.’ It sold ₩74.1 billion last year according to IQVIA. As the combination of the two drugs is also commonly used in metastatic or early breast cancer., the release of a combined, fixed-dose formulation is expected to greatly improve the dosing convenience of patients. Phesgo is a subcutaneous formulation injected in the thigh that offers faster administration than standard intravenous administration. Herceptin is available as a subcutaneous formulation, however, Perjeta is only approved as an intravenous formulation. Patients who are receiving Herceptin and Perjeta intravenously may switch to Phesgo. Also, patients who receive Phesgo subcutaneously may switch to intravenous injection of Herceptin and Perjeta. Phesgo is approved for use in combination with docetaxel in patients with metastatic or unresectable locally advanced HER2-positive breast cancer who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer. Phesgo may be used as neoadjuvant treatment in combination with chemotherapy in patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (tumor is greater than 2 cm in diameter). In addition, Phesgo is used as an adjuvant treatment in combination with chemotherapy in patients with HER2-positive early breast cancer who have a high likelihood of coming back. At the PHranceSCa(MO40628) clinical trial on 160 patients, 136 patients, 85% (136 participants) had reported that they prefer Phesgo over intravenous administration of trastuzumab and pertuzumab. The patients chose the reduced period of administration in the hospital as the reason for their preference. Biosimilars of Herceptin’s trastuzumab are being sold by various companies including Celltrion and Samsung Bioepis. Roche expects the release of Phesgo to provide an edge in its competition with biosimilars. Phesgo was approved by the US FDA in July last year and by the EMA in December last year.
- Policy
- Letrozole for ovulation-inducing use is not allowed
- by Lee, Hye-Kyung Sep 07, 2021 05:53am
- An application to use Letrozole (Bretra, Femara, Letrozole) as non-reimbursment has been rejected. The HIRA is receiving applications in advance for the use of non-reimbursement from the MFDS to prevent the use of drugs that lack medical grounds or are concerned about safety. According to The HIRA's recent details of "disapproval of use for non reimbursement drugs," nine cases of non-approval, including Letrozole, have been added, bringing a total of 212 cases of non-approval. The medical institutions prescribed Bretra, Femara and Letrozole applied to the HIRA to combine ovarian stimulation with reproductive gland stimulants for preservation of fertility in breast cancer patients, but were rejected due to insufficient medical evidence. Clipper Enteric Coated Tab 5mg has not been allowed for patients with GVHD symptoms, and 'Lucentis Prefilled Syringe' has been approved for retinal hematoma patients with no improvement due to laser photocoagulation and cryotherapy. Non-reimbursment applications for Botox for chronic hypothritis patients and adult peritoneal pain syndrome patients over the age of 20 have also been rejected to use "Vfend 200mg" for patients with guided inflammation suspected of fungus alone or simultaneously. An application to administer "Xeljanz 5 or 10mg" to patients with combustible skin musculitis who are 2 years old or older who do not comply with other drugs has also not been approved. The application to dilute the Isopto Atropine 1% eye drops to 0.9% Sod. Chloride in pediatric patients with myopia of minus 1.0 diopters or more between the ages of 4 and 12 has also been rejected.
- InterView
- Treatment-free remission drug for chronic myeloid leukemia
- by Sep 07, 2021 05:53am
- The introduction of the world’s first targeted anticancer drug ‘Gleevec,’ has brought a revolutionary change in the field of chronic myeloid leukemia (CML) treatment. Patients who mostly died if they were unable to receive hematopoietic stem cell transplantation, may now not only survive long-term but can maintain a high quality of life and even discuss the possibility of treatment-free remission (TFR), where a patient can maintain a state of remission in their cancer cells even after discontinuing his/her treatment. Analysis shows that the possibility of TFR is determined by the response to the drug used in the initial stages of treatment. This means that patients with a higher rate of achieving an early molecular response (EMR, BCR-ABL1 (IS) ≤10%) at 3 months of treatment are more likely to be able to discontinue drug treatment in the future. And selecting an appropriate targeted therapy is of utmost importance in achieving such a high response in the early stages of treatment. Patients diagnosed with CML may select one of the 5 first-line treatments: the 1st generation drug ‘Gleevec (imatinib),’ the 2nd generation ‘Sprycel (dasatinib),’ ‘Tasigna (nilotinib),’ ‘Supect (ladotinib),’ ‘Bosulif (bosuinib).’ Each drug has a different method of intake, effect and side effects, and therefore a drug suited for each patient should be selected according to the patient’s characteristics. The Hemato-Oncology Professor Dongwook Kim of the Uljeongbu Eulji Medical Center, who is known as the authority in CML treatment, said, “We need to search for the best drug for each patient should be identified by monitoring the patient’s condition for around a year.” Kim added, “It is the ability of the doctor to tune the regimen while maintaining a treatment response. As compliance is crucial, choosing the right drug that fits each patient’s lifestyle, as well as appropriate medication education, is also very important." Dailypharm met with Professor Kim to hear about how to select the appropriate treatment for TFR in CML. Dongwook Kim, Professor of Hemato-Onocology, Uljeongbu Eulji Medical Center, Eulji University. -Discussion of treatment-free remission (TFR) has been ongoing in CML during the past few years. I believe patients would be very interested in achieving TFR. =Around half of the 2,200 patients I treat may take the drug discontinuation approach. Around 200 patients (that participated in clinical trials) have discontinued their drugs. The patient who had stayed off the drug the longest has discontinued taking medications for 17 years since 2004. His cancer cell level had risen and fell at a low rate and then turned 0 about three times in the first year, and has had no problem ever since. -If around half of the patients have the possibility of achieving TFR, that is quite much, isn’t it? =It is. And this is now possible due to the improvement of drugs. However, the important consensus on when and how the patients should be treated. has not been reached yet. Until now, patients who received drug treatment for at least 3 years and maintained their condition for at least 2 years, and showed a sustained molecular response (level of 0 in a genetic test) discontinued their drugs. We conducted a study on discontinuing Gleevec with the 2010-2015 patient data provided by the Ministry of Health and Welfare. Data showed that around 50% of the patients who received drug treatment for at least 3 years and showed genetic test results of 0 for at least 2 years relapsed. 2 patients have died from disease progression, and one patient is being treated using a different drug. Globally, around 1% of the patients who discontinue treatment may be at risk, and around half experience recurrence. Of course, most of these relapsed patients who receive drug treatment again become better. -Patients who have a white blood cell count of 10% or less at 3 months have the possibility of TFR. What factors contribute to achieving a good response in the early stages of treatment? =Prognosis differs greatly according to the drugs you select, so accurate drug selection is important. And patients experience a lot of side effects in the first 3 months of using anticancer drugs. Therefore, you cannot use the full dose during that period, and many patients discontinue or reduce their dose. The first three months are an important period in which treatment decisions may vary depending on whether patients respond or not respond to treatments as well as compliance. A treatment-naive patient can choose from one of five targeted anticancer therapies. In choosing the one treatment, all features of the patient’s character need to be from age, gender, food preference, to his/her family medical history. The patient may choose their treatment from the scope of the information they know. I will be presenting on ‘How I select targeted anticancer therapies in CML’ at the International Conference on Hematology and Blood Disease in October. -Could you tell us in more detail what needs to be considered in determining what drug is appropriate for which patient? =You could largely consider three things. What underlying disease does the patient have? I check for diabetes, high blood pressure, high cholesterol, etc. to account for the side effects of the targeted anticancer therapies. Each anticancer drug has different side effects, and using a targeted therapy that has the side effect of increasing one’s blood pressure may treat his/her CML, but would require separate treatment for diabetes. Some drugs from blood clots or raise the cholesterol level of a patient as a side effect. Also, age is important. In particular, the prevalence of leukemia increases with age, and patients may develop CML at 70. Cells also age with humans in the aging process, and blood cells die faster with age Therefore, whether to use the 2nd or 3rd generation drugs that have much potent effect over Gleevec becomes the question. For patients in their 70s, prolonging survival to 10 or 15 years with less potent drugs that have fewer long-term side effects may be more important than being fully cured. Genetic mutations are also an important consideration. However, how the mutations affect treatment was not clearly identified, so we use the ELTS score to predict the differences in prognosis, by low-risk, moderate-risk, and high-risk patients. If we can find a gene that can predict the treatment effect using next-generation sequencing, it would become an important biomarker in the treatment of CML. -Does that mean the first-generation treatment is better for the elder patients and second-generation treatment is better for the younger patients? =Yes. Compared to Gleevec, second-generation treatment is approximately 20 times, to even 325 times in the case of Sprycel, with varying side effects. Patients who use Sprycel long term may develop pleural effusion, a condition where water fills up in the lungs. Tasigna can increase the risk of blood clots in the heart and brain by 25% in 10 years, and by 10 times in the same age range. Supect can increase blood glucose levels. Tasigna and Supect have slightly more side effects, increasing glucose levels or cholesterol levels than other drugs. Therefore, older patients that use such drugs may develop arteriosclerosis and significantly increase the probability of developing myocardial infarction, cerebral infarction, or thrombosis. So if a patient has a family history of hypertension or hyperlipidemia, the use of the two drugs I mentioned should be ruled out. This is simply looking at the side effects, and we also need to consider the presence of additional chromosomal abnormalities, additional genetic mutations, and other factors of high-risk groups, to select the drug with the lowest risk of developing side effects for each patient’s underlying condition among the second-generation drugs. Therefore, prescriptions made by each doctor for the same patient may differ by doctor. In particular, hospitals with a low prevalence and incidence rate may tend to prescribe a particular drug. Hospitals like Uljeongbu Eulji Medical Center which has a large CML patient population may be better in the selection of drugs and treatment. For example, some patients of mine came from hospitals that rarely treat CML patients after failing treatment. And I sometimes wonder why they used that drug for the patient. Also, records show many failures to treatment where the appropriate dose was not used, etc. It may also be due to side effects from other drugs that the patients had originally taken. -Also, the doing regiment for each drug is also different. This may also affect the selection of treatment according to each patient’s lifestyle. =That is true. Sprycel is taken once a day, and Tasigna or Supect is taken twice a day. Tasigna or Supect is taken in an empty stomach, so it needs to be taken 1-2 hours before or after meals, but Sprycel does not have such limitations. It has better dosing convenience as it just needs to be taken regularly once a day. In particular, patients who work night shifts or work 3 shifts, like nurses, may have trouble taking a drug twice daily. Therefore, according to each patient’s occupation and lifestyle, one of the two options – of taking drugs once or twice – may be selected. It is already a wide known fact that taking the medicine correctly without skipping is good for treatment. Discontinuing a drug can develop tolerance to the drug, and reduce the treatment effect. This is more important for drugs that are taken daily. Therefore, such a method of administration may be a serious and even critical issue for some occupations. Dosing education has become increasingly important as drug compliance is a very serious issue. A European patient group, CML Advocate, surveyed tens of thousands of patients about drug administration, and only 70% of the patients responded that they took their medication as prescribed for three days in a month. 30% did not take the drug properly for over 4 days a month. Surprisingly enough, about 60% of patients have used and survived using Gleevec since its introduction. This is in line with the medication compliance rate. In this sense, compliance to treatment is very important and discussed often. In that sense, dosing compliance of Sprycel, which is taken once a day and can be taken with or without meals, is much higher than other drugs. -In other words, making the effort to find the optimal drug for each patient according to each patient’s underlying condition and lifestyle is the most important process? =That is right. If someone asks when should we search for the right drug, I would say 1 year. I tell my patients that I would be tuning the dose for the patient while monitoring their response and side effects. It is the ability of the doctor to tune the regimen while maintaining a treatment response. And that difference is what makes one doctor more skillful than the other. One of the most frequently asked questions in lectures is what drug I would choose. And I always say, ‘There is no one drug that is best for all patients.’ We need to find the best drug for each patient.
- Company
- Tagrisso has established itself as an EGFR treatment
- by Sep 07, 2021 05:53am
- Lung cancer is the No. 1 cancer death rate among Koreans, but treatment is greatly evolving, with the 5-year survival rate more than tripling over 20 years. What had a significant impact on this was the EGFR target treatment. Targeted treatments targeting EGFR mutations have dramatically improved the overall survival period of patients. Among them, the third generation 'Tagrisso (Osimertinib)' has clearly established itself as a standard treatment for non-small cell lung cancer with current EGFR mutations. Tagrisso is a third-generation EGFR-TKI that inhibits both EGFR variations and T790M variations represented by L858R and exon 19 deficiencies. It is the only third-generation EGFR-TKI that has shown a full survival period of more than three years, which is excellent for patients with brain metastasis. AstraZeneca succeeded in the first generation of Iressa and the third generation of Tagrisso. Tagrisso's global sales reached $4.33 billion as of last year, becoming the first blockbuster drug in five years. Ironically, Tagrisso is going through all sorts of ups and downs in Korea. It's been a problem since the first registration. Since its first rapid approval in the United States in November 2015, Tagrisso has been the fifth in the world to obtain an item permit in Korea. At that time, Olita, the same third generation, was released in Korea. Tagrisso was the only third-generation drug in the world, but competed with Olita in Korea. Tagrisso was "too expensive" for the government, compared to Olita, which offered relatively low prices. In November 2016, the HIRA declared Tagrisso as a non-reimbursement drug, equivalent to the economic evaluation exception scheme. It passed the committee after three challenges, but negotiations with the NHIS were not easy. It was first listed as a secondary treatment in December 2017. Olita's development was suspended due to safety issues, and Tagrisso's quarterly sales jumped from ₩3 billion to ₩10 billion based on IQVIA. However, the Asian subanalysis data of the 2019 FLAURA 3-phase study became a problem. FLAURA is a global clinical trial that identifies Tagrisso's efficacy and safety as a primary treatment. Overall clinical results demonstrated improvement over first-generation drugs with a total survival period of 38.6 months. The problem was the result of a sub-analysis that only Asians did separately. The risk ratio (HR) of the Asian subgroup is 0.995, which is virtually no difference from the control group based on 1. AstraZeneca also submitted FLAURA China data for Chinese to reaffirm its effectiveness in Asians, but failed to pass the Cancer Drugs Benefit Appraisal Committee. Two years have passed since the first treatment indication was added, but conditions have no longer evolved since December 2017. Tagrisso's sales are steadily increasing. According to IQVIA, Tagrisso's annual sales reached ₩59.4 billion in 2018 and ₩79.2 billion in 2019. Last year, its annual sales surpassed ₩100 billion for the first time with ₩106.5 billion. It has become a global primary standard treatment. This year, Tagrisso's situation is not so good. First of all, after Olita, Yuhan's Leclaza is the second competitive drug. The UK, which was passive in primary care benefits due to its high cost, also recognized Tagrisso as primary standard treatment last year and applied the benefits. Currently, 44 countries around the world, including the United States, Britain, Germany, France, Italy and Japan, recognize Tagrisso as a primary treatment. Despite the controversy over the Asian OS, major Asian countries recognize Tagrisso as a primary treatment. Tagrisso is also applied as the first benefit in major Asian countries such as Japan, China, Taiwan and Singapore. After all, Tagrisso's benefit is an irresistible global trend. However, as two years have passed, complaints from patients are growing. It is noteworthy whether Tagrisso will be able to cross the high barrier of salary expansion amid changes in global treatment flow and demands from patients.
