Roche’s Herceptin+Perjeta combo is approved in Korea

Will increase share in breast cancer treatment market

Patients who previously used the two drugs in combination may switch to the fixed-dose subcutaneous formulation… dosing convenience was dramatically improved

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.