FDA approves Imbruvica for mantle cell lymphoma

Drug, co-marketed by J&J and Pharmacyclics, is second to receive approval as breakthrough therapy

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

The FDA announced the approval of Imbruvica (ibrutinib), marketed by Pharmacyclics and Johnson & Johnson, for treating mantle cell lymphoma, or MCL. MCL is a rare form of non-Hodgkin lymphoma and represents about 6% of all non-Hodgkin lymphoma cases in the United States. Millennium Pharmaceuticals' Velcade (bortezomib) and Celgene's Revlimid (lenalidomide) are also approved for treating MCL.

Imbruvica is the second drug with the FDA's breakthrough therapy designation to receive approval from the agency. The FDA Safety and Innovation Act, passed in July 2012, gave the agency the ability to designate a drug a breakthrough therapy at the request of the company seeking approval if preliminary clinical evidence indicates it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. Genentech's Gazyva (obinutuzumab), for chronic lymphocytic leukemia, was the first designated breakthrough therapy to receive FDA approval, earlier this month.

"Imbruvica's approval demonstrates the FDA's commitment to making treatments available to patients with rare diseases," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "The agency worked cooperatively with the companies to expedite the drug's development, review and approval, reflecting the promise of the Breakthrough Therapy Designation program."

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