U.S. Food and Drug Administration Approves IMBRUVICA™ (ibrutinib) as a Single Agent for Patients with Mantle Cell Lymphoma

New Drug Approvals

FDA OKs ‘Breakthrough’ Drug Imbruvica

 U.S. Food and Drug Administration Approves IMBRUVICA™ (ibrutinib) as a Single Agent for Patients with Mantle Cell LymphomaWho Have Received at Least One Prior Therapy, a rare and aggressive type of blood cancer
Corporate Conference Call Scheduled Today at 10:00 AM PT, November 13, 2013http://www.pharmalive.com/fda-oks-breakthrough-drug-imbruvica

SUNNYVALE, Calif., Nov. 13, 2013 /PRNewswire/ — Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1 This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. IMBRUVICA is a new agent that inhibits the function of Bruton’s tyrosine kinase (BTK).1 BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the…

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