FDA OKs Janssen’s Darzalex for Multiple Myeloma

FDA has approved Janssen Pharmaceutical Companies’ Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Approval was based on data from the Phase 3 MAIA (MMY3008) clinical study, which showed that the combination significantly reduced the risk of disease progression or death by 44% compared to treatment with lenalidomide and dexamethasone alone. The NDA was approved through FDA’s Real-Time Oncology Review pilot program.

On the safety side, the study showed that the most frequent adverse reactions were infusion reactions, diarrhea, constipation, nausea, peripheral edema, fatigue, back pain, asthenia, pyrexia, upper respiratory tract infection, bronchitis, pneumonia, decreased appetite, muscle spasms, peripheral sensory neuropathy, dyspnea and cough. Serious adverse reactions with a 2% greater incidence in the Daralex arm compared to the lenalidomide and dexamethasone arm were pneumonia (15% vs. 8%), bronchitis (4% vs. 2%) and dehydration (2% vs. 1%).