FDA Grants Accelerated Approval to Daratumumab for Multiple Myeloma

The U.S. FDA granted accelerated approval to daratumumab injection for patients with multiple myeloma (MM) who have failed at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Daratumumab is the first monoclonal antibody approved for the treatment of MM.

The recommended dose of daratumumab is 16 mg/kg administered once every week for eight weeks, then once every two weeks for 16 weeks, followed by once every four weeks until disease progression.

The approval was based on a multicenter, open-label study evaluating response rates in 106 patients with relapsed or refractory MM treated with daratumumab monotherapy. The objective response rate was 29 percent (95% CI 21-39%) with a median response duration of 7.4 months (range = 1.2-13.1 months).

The most common treatment-related adverse events (occurring in ≥20% of patients) included infusion reactions, fatigue, nausea, back pain, pyrexia, cough, and upper respiratory tract infection. In addition, the most common laboratory abnormalities were lymphopenia, neutropenia, anemia, and thrombocytopenia.

In its news release, the FDA noted that blood banks should be informed that patients are receiving daratumumab because the drug may interfere with certain tests that are done by blood banks (such as antibody screening) for patients who need a blood transfusion.

Daratumumab was approved under the FDA’s accelerated approval program, which allows the approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. As a condition of approval, Janssen Biotech, Inc., the drug’s manufacturer, is required by the FDA to perform a multicenter, randomized trial establishing the superiority of daratumumab over standard therapy to verify and describe the drug’s clinical benefit.

Source: U.S. FDA press release, November 16, 2015.

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