Mantle cell lymphoma: FDA approves new drug

November 13, 2013 | by Tami Dennis

Imbruvica. Unless you or a loved one have mantle cell lymphoma, the word is likely unfamiliar. If you do have the disease, the news that the Food and Drug Administration (FDA) on Wednesday approved the drug for mantle cell lymphoma is significant.

FDA approves drug for mantle cell lymphoma. The Food and Drug Administration has approved a new drug for mantle cell lymphoma, a rare and difficult-to-treat disease that accounts for about 6 percent of all non-Hodgkin lymphoma cases in the U.S.

Mantle cell lymphoma is a rare type of non-Hodgkin lymphoma – and it’s difficult to treat. Imbruvica, which inhibits the enzyme that the cancer needs to multiply and spread, is only the third drug approved specifically to treat mantle cell lymphoma.

The new drug, with the generic name ibrutinib, was approved for patients who have already received at least one form of therapy.

Leslie L. Popplewell, M.D., an associate clinical professor at City of Hope and an expert in hematologic malignancies, believes that the drug could have a real impact.

“Mantle cell lymphoma is an uncommon lymphoma and well-known for poor prognosis,” she said. “Unlike other entities like diffuse large B-cell lymphoma, it is not curable with conventional chemotherapy approaches. Young patients who are newly diagnosed are treated with aggressive chemotherapy, and often with autologous transplant in first remission.”

The drug, which has the FDA’s breakthrough therapy designation, was approved under an accelerated approval program  based on a study of 111 people. That study showed that cancer shrunk or disappeared in 66 percent of participants.

“It is hard to know where ibrutinib will eventually fall in the treatment schema for MCL – it is not an option for newly diagnosed patients, for example, but it is an important new drug in our arsenal,” Popplewell said. “Being available in pill form makes it especially attractive as a treatment option for patients because it allows them to have fewer disruptions in their daily activities."



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