Angiogenesis Foundation

Bayer’s Stivarga (regorafenib) Tablets Approved By U.S. FDA For Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic GIST
February 27, 2013

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., Feb. 25, 2013 /PRNewswire/ – Intended for U.S. Media Only – 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 to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.1 Stivarga was approved by the FDA in September 2012 for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.1 “The FDA’s decision marks the second approval for Stivarga – first in metastatic colorectal cancer last year and now in locally advanced, unresectable or metastatic GIST, where there is a high unmet medical need for patients who have exhausted all approved treatment options,” said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “These regulatory milestones underscore Bayer’s commitment to deliver effective products for difficult-to-treat cancers.”

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