Κυριακή, 22 Νοεμβρίου 2015

DARATUMUMAB APPROVED FOR MYELOMA

Today the U.S. Food and Drug Administration granted accelerated approval for daratumumab (Darzalex) to treat patients with multiple myeloma who have received at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent. Daratumumab is the first monoclonal antibody approved for treating multiple myeloma.
“Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “[Daratumumab] provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.”
Daratumumab injection, given as an infusion, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.
Clinical Trial Results
The safety and efficacy of daratumumab were demonstrated in two open-label studies. In one study of 106 participants receiving daratumumab, 29% of patients experienced a complete or partial reduction in their tumor burden, which lasted for an average of 7.4 months. In the second study of 42 participants receiving daratumumab, 36% had a complete or partial reduction in their tumor burden.
The most common side effects of daratumumab were infusion-related reactions, fatigue, nausea, back pain, fever, and cough. Daratumumab may also result in lymphopenia, neutropenia, leukopenia, anemia, and thrombocytopenia.
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. Women who are pregnant should not use daratumumab, and women planning to become pregnant should use effective contraceptives during and for at least 3 months after treatment.
The FDA granted Breakthrough Therapy designation for this application based on preliminary clinical evidence suggesting that if approved, daratumumab may offer a substantial improvement over available therapies. The drug also received Priority Review and Orphan Drug designations.

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