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FDA Approves Ibrutinib (Imbruvica) for Rare Blood Cancer

Second drug with ‘breakthrough therapy’ designation to get agency nod (November 13)

The FDA has approved ibrutinib (Imbruvica, Pharmacyclics/Janssen Biotech) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin lymphoma (NHL). MCL represents about 6% of all NHL cases in the U.S.

Ibrutinib is intended for patients with MCL who have received at least one prior therapy. The drug works by inhibiting the enzyme needed by the cancer to multiply and spread. Ibrutinib is the third drug approved to treat MCL. Bortezomib (Velcade, Millennium/Takeda; 2006) and lenalidomide (Revlimid, Celgene; 2013) are also approved to treat the disease.

Ibrutinib is the second drug with a “breakthrough therapy” designation to receive FDA approval.

The accelerated approval of ibrutinib for MCL is based on a study in which 111 participants were treated with the drug daily until their disease progressed or side effects became intolerable. The study showed that nearly 66% of participants had their cancer shrink or disappear after treatment (overall response rate). An improvement in survival or disease-related symptoms has not been established.

The most common side effects reported in subjects receiving ibrutinib include thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting, and decreased appetite. Other clinically significant side effects include bleeding, infections, kidney problems, and the development of other types of cancers.

Source: FDA; November 13, 2013.

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