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Pharmacyclics Incorporated

FDA speedily approves Imbruvica, a treatment for rare lymphoma

FDA speedily approves Imbruvica, a treatment for rare lymphoma

Less than five months after a pair of biotech companies submitted a candidate cancer drug to the Food & Drug Administration, the FDA has approved the drug ibrutinib as a "breakthrough therapy" for a rare and deadly form of the cancer, mantle cell lymphoma. The new medication, to be marketed under the commercial name Imbruvica, becomes a new option for patients who are diagnosed with this malignancy of the immune system's B-cells and who have received at least one prior therapy. The medication is the first product developed by Sunnyvale, Calif., biotech firm Pharmacyclics, where its promise as a treatment for B-cell malignancies such as lymphoma became evident in 2009....

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