Bayer Healthcare, a part of German drug maker Bayer AG (BAYRY.PK,BAYZF.PK,BYR.L), announced Monday that the U.S. Food and Drug Administration has approved its Stivarga tablets as a treatment for one of the most common tumors of the gastrointestinal tract.
The drug is indicated for patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
Stivarga or regorafenib, is an oral multi-kinase inhibitor that targets oncogenesis, tumor angiogenesis and maintenance of the tumor microenvironment signaling by inhibiting multiple protein kinases.
Regorafenib is a compound developed by Bayer Healthcare and jointly promoted by Bayer and California-based Onyx Pharmaceuticals, Inc. (ONXX) in the U.S. as per a 2011 deal, under which Onyx will receive a royalty on all global net sales of regorafenib in oncology.
Bayer's potential blockbuster cancer Stivarga was earlier approved by the FDA in late September for the treatment of patients with metastatic colorectal cancer (mCRC).
"The second approval for Bayer's Stivarga in the U.S. reveals the drug's potential to fulfill serious unmet medical needs for patients with cancer who require new medicines that continue to slow the progression of their disease," the company said in a statement.
The FDA approval is based on results from the pivotal late stage study that demonstrated significant improvement in progression-free survival (PFS) compared to placebo in patients with GIST whose disease had progressed after treatment with imatinib mesylate and sunitinib malate.
Stivarga was developed under the Fast Track program and received priority review designations for metastatic or unresectable GIST and mCRC from the FDA in late June 2012 after the drug met its primary goals in late-stage study of patients with GIST in early June.
These designations are granted by the FDA to expedite the development and review of drugs to treat serious diseases and fulfill an unmet medical need, and are given to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.
In December 2012, Bayer submitted a filing to the Ministry of Health, Labour and Welfare or MHLW, in Japan for regorafenib for the treatment of GIST. An NDA for regorafenib for the treatment of advanced CRC filed in July 2012 with the MHLW in Japan was also granted priority review in early September.
GIST is the most common form of sarcoma arising from the muscle wall of the gastrointestinal tract. GIST represents a life-threatening malignancy if the disease has spread to other parts of the body (metastasized) or is unable to be surgically removed with curative intent. The incidence of GIST is estimated to be 11 to 20 patients per million per year.
On Frankfurt's Xetra, Bayer shares closed Monday's regular trading at 73.75 euros, up 0.75 euros or 1.03% on a volume of 2.92 million shares.
by RTT Staff Writer
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