FDA Approves Imbruvica (ibrutinib) for Mantle Cell Lymphoma

The U.S. Food and Drug Administration today has approved Imbruvica (ibrutinib) for the treatment of mantle cell lymphoma (MCL).

MCL is a rare form of B-cell non-Hodgkin's lymphoma (NHL), representing about 6 percent of all NHL cases in the United States. It is difficult to treat, with some patients having indolent disease and others having aggressive disease.

Breakthrough therapy approval

Imbruvica is intended for patients with MCL who have received at least one prior therapy. It works by inhibiting the enzyme needed by the cancer to multiply and spread. Imbruvica is the third drug approved to treat MCL. Velcade (2006) and Revlimid (2013) are also approved to treat the disease.

Said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research:

Imbruvica’s approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases. 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.

Imbruvica is the second drug with breakthrough therapy designation to receive FDA approval. The Food and Drug Administration Safety and Innovation Act, passed in July of 2012, gave the FDA the ability to designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.

Encouraging results

Imbruvica’s accelerated approval is based on a study of 111 patients given Imbruvica daily until their disease progressed or side effects became intolerable. Results demonstrated that nearly 66 percent of participants had their cancer shrink or disappear after treatment (overall response rate, or ORR). An improvement in survival or disease-related symptoms has not been established.

Source: FDA