Will the third time be the charm for Mylotarg?

A new drug for leukemia applies for reimbursement coverage for the third time in Korea

Expected to be presented for DREC review within the year

Reimb discussions fell through after passing CDDC review last year

The industry’s attention is focused on whether the insurance reimbursement discussions for the acute myeloid leukemia drug ‘Mylotarg’ will make progress this time.

 

According to the industry sources, Pfizer Korea’s acute myeloid leukemia (AML) drug ‘Mylotarg (gemtuzumab ozogamicin)’ is set to be submitted to the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee.

 

However, it is not yet confirmed whether the agenda it will be presented in November.

 

Mylotarg’s reimbursement agenda was deliberated by HIRA’s Cancer Disease Review Committee in May 2022 but was unable to set reimbursement standards then.

 

It passed the CDDC review in October last year, but subsequent discussions had collapsed.

 

Pfizer resubmitted the application for its reimbursement in June, which passed the Pharmacoeconomic Evaluation Subcommittee.

 

Mylotarg is an antibody-drug conjugate (ADC) indicated for the first-line treatment of newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML) .

 

The drug, which received marketing authorization in Korea in December 2021, is an ADC composed of a CD33-targeting monoclonal antibody linked to calicheamicin, a potent cytotoxic agent.

 

The drug works on cells that express the CD33 antigen, which is expressed in more than 90% of AML patients.

 

 This blocks cancer cell growth and induces apoptosis.

 

Mylotarg’s approval was based on a clinical trial (ALFA-0701) conducted on 271 patients aged between 50 to 70 with newly diagnosed AML with no prior treatment experience.

 

The ALFA-0701 trial was an open-label, randomly assigned, multicenter Phase III study that compared the existing standard front-line chemotherapy, daunorubicin+cytarabine combination therapy, with Mylotarg+ daunorubicin+ cytarabine combination therapy.

 

Results showed that the median event-free survival (EFS) in the Mylotarg+daunorubicin+cytarabine combination therapy group was 17.3 months, a 7.8 month extension compared to the 9.5 months in the daunorubicin+cytarabine combination therapy group.

 

Also, the Mylotarg combination therapy reduced the risk of induction failure, relapse, or death by 44% compared to chemotherapy alone.

 

The median relapse-free survival (RFS) was 28.0 months in the Mylotarg+daunorubicin+cytarabine combination therapy group and 11.4 months in the daunorubicin+cytarabine combination therapy group, showing a significant 16.6-month difference with the addition ofMylotarg.

 

In the case of median overall survival (OS), the median OS was 27.5 months in the Mylotarg+daunorubicin+cytarabine combination therapy group and 21.8 months in the daunorubicin+cytarabine combination therapy group, but there was no statistically significant difference between treatment arms in OS.

 

Meanwhile, Mylotarg is administered intravenously under close monitoring over 2 hours at the recommended dose with dilution depending on the treatment regimen, including remission induction therapy and remission maintenance therapy.

 

Mylotax was approved by the U.S.

 

FDA in September 2017 and by the European Medicines Agency (EMA) in April 2018.