FDA Committee Recommends Approval of Mylotarg to Treat Newly Diagnosed AML

FDA Committee Recommends Approval of Mylotarg to Treat Newly Diagnosed AML

The Oncologic Drug Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) supports the approval of Pfizer’s Mylotarg (gemtuzumab ozogamicin), in combination with standard chemotherapy, for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML).

Pfizer anticipates the FDA to make a final decision on the Mylotarg application by September.

“We are extremely pleased with the Committee’s recommendation and believe this is an important step toward our goal of making Mylotarg available to patients with newly-diagnosed AML,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer Global Product Development, said in a press release.

“We look forward to working closely with the FDA as we continue the regulatory process. We are grateful to both the investigators who led Mylotarg clinical trials and the patients who participated,” Rothenberg said.

Mylotarg is an antibody-drug conjugate that targets CD33, a protein found in more than 90 percent of AML cells. When the antibody binds to CD33 on the surface of leukemia cells, it is internalized and releases a toxic payload that is bound to it – calicheamicin – which then induces leukemia cell death.

The committee’s recommendation was based on the results from several Pfizer-sponsored clinical studies, including the investigator-led Phase 3 ALFA-0701 study (NCT00927498), and a meta-analysis of data collected from five Phase 3 studies. This overall clinical evaluation took about 10 years, and included more than 4,300 patients.

“Clinical studies investigating Mylotarg have provided a significant body of evidence supporting the risk:benefit profile of Mylotarg in AML,” said Jorge Cortes, MD, University of Texas MD Anderson Cancer Center. “Based on the totality of the efficacy and safety data, Mylotarg, if approved, has the potential to be an important treatment option for adult patients with AML.”

Based on the results of the ALFA-0701 trial, the committee voted 6-1 in favor of Mylotarg’s approval. They considered that administration of Mylotarg (3 mg/m2) on days one, four, and seven, in combination with cytarabine and daunorubicin chemotherapy, induced significant clinical benefit for patients with newly diagnosed CD33-positive AML.

Mylotarg is currently available in Japan for the treatment of patients with relapsed or refractory CD33-positive AML who are not considered suitable candidates to receive other chemotherapies.

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