2 Recent FDA Approvals

04 Oct 2012 1:12 PM | Lori Aubrey (Administrator)
Bayer’s Stivarga® (regorafenib) Tablets Approved by U.S. FDA for Treatment of Metastatic Colorectal Cancer

Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the U.S. Food and Drug Administration (FDA) approved Bayer’s Stivarga® (regorafenib) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy).1

U.S. Food and Drug Administration Approves BOSULIF® (bosutinib) for Patients with Previously Treated Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia (CML)

September 4, 2012 - Pfizer Inc. announced today the U.S. Food and Drug Administration (FDA) has approved BOSULIF® (bosutinib), an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy. Patients in the registrational trial included patients who were previously treated with imatinib [Gleevec®] or imatinib plus at least one second generation tyrosine kinase inhibitor (TKI).1 Once daily BOSULIF represents the only therapy approved with pivotal trial data that included CML patients treated with imatinib followed by a second generation TKI.

Read about these and other FDA Approvals!


Northern New England Clinical Oncology Society
P.O. Box 643
Sandown, NH 03873-0643
Telephone (603) 887-1948

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