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FDA advisory committee supports Mylotarg for acute myeloid leukemia

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An FDA advisory committee today expressed its support for gemtuzumab ozogamicin as part of combination therapy for certain patients with acute myeloid leukemia.

Gemtuzumab ozogamicin (Mylotarg, Pfizer) is a recombinant, humanized anti-CD33 antibody–drug conjugate.

The FDA approved the product via accelerated review in May 2000 for monotherapy of elderly individuals with relapsed AML.

However, Pfizer voluntarily withdrew the agent from the market in June 2010 after results of a postmarketing clinical trial showed the drug increased risk for death but conferred no additional benefit compared with other conventional therapies.

Pfizer resubmitted a biologics license application that sought approval of gemtuzumab ozogamicin in combination with daunorubicin and cytarabine for treatment of adults with treatment-naive CD33–positive AML.

The Oncologic Drugs Advisory Committee voted 6-1 that the combination has a favorable risk–benefit profile.

“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 for oncology with 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.”

The FDA is scheduled to make a decision on the application by Sept. 27. The FDA often follows the guidance of the Oncologic Drugs Advisory Committee when making its final decision, but the agency is not obligated to do so.

Pfizer’s application included data from the randomized phase 3 ALFA-0701 study, which evaluated gemtuzumab ozogamicin in combination with standard induction chemotherapy administered in an alternative fractionated dosing schedule. The analysis included 278 adults (age range, 50 to 70 years) with de novo AML.

The final analysis showed gemtuzumab ozogamicin–treated patients achieved significantly higher rates of 3-year EFS (31% vs. 19%; HR = 0.66; 95% CI, 0.5-0.87) and 3-year RFS (38% vs. 25%; P = .006). Researchers also observed a 3-year OS benefit with gemtuzumab ozogamicin (44% vs. 36%; HR = 0.82; 95% CI, 0.6-1.1), but the difference did not reach statistical significance.

The application also included data from Pfizer-sponsored studies from the original new drug application, as well as a meta-analysis of more than 3,000 patients who participated in five randomized phase 3 studies, including ALFA-0701.

“Clinical studies investigating Mylotarg have provided a significant body of evidence supporting the risk–benefit profile of Mylotarg in AML,” Jorge Cortes, MD, deputy department chair of the department of leukemia at The University of Texas MD Anderson Cancer Center, said in the release. “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.”

Castaigne S, et al. Abstract #376. Presented at: ASH Annual Meeting and Exposition; Dec. 6-9, 2014; San Francisco.