Pfizer Korea said that the Ministry of Food and Drug Safety has approved Mylotarc as the first-line treatment of newly diagnosed CD33-positive adult patients with acute myeloid leukemia (AML).

The ministry based its approval on an open-label, randomized, multicenter, phase 3 ALFA-0701 clinical trial in 271 AML patients aged 50-70 years old.

As a result of comparative evaluation of the existing chemotherapy daunorubicin and cytarabine combination therapy and Mylotarc, daunorubicin, and cytarabine combination therapy, the median event-free survival for the Mylotarc group was 17.3 months, which was 7.8 months longer than the 9.5 months in the control group.

The company also found that the Mylotarc group reduced the risk of induction failure, recurrence, and death by about 44 percent.

Regarding relapse-free survival (RFS) and overall survival (OS), the Mylotarc group showed a median RFS and OS of 28 and 27.5 months compared to the control group's 11.4 months and 21.8 months.

With the approval, Mylotarc has become the first and only targeted treatment option for patients with CD33-positive AML in Korea.

“The company is happy to be able to provide an effective treatment option for patients with CD337-positive AML with a high expression rate through the approval of Mylotarc,” Pfizer APAC Medical Affairs Lead Mahmood Alam said. “Pfizer Korea will continue to strive to contribute to the treatment of cancer patients with high unmet needs, including blood cancer, through innovative therapeutics.”

Mylotarc is an antibody-drug conjugate composed of a CD33-targeting monoclonal antibody and the cytotoxic drug calicheamicin. It acts on cells expressing the CD33 antigen, seen in 90 percent of all AML patients, blocking the growth of cancer cells and inducing apoptosis.