Bayer's Stivarga Gets Approval In Japan To Treat Gastrointestinal Stromal Tumors

Bayer HealthCare, a subgroup of Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK), said Tuesday that it has received approval from the Ministry of Health, Labor and Welfare or MHLW in Japan for the marketing of Stivarga or regorafenib for the treatment of patients with gastrointestinal stromal tumor or GIST who have progressed after prior systemic cancer therapy. This marks the second indication approved for Stivarga in Japan.

The company said that the approval of Stivarga was based on the positive results from the pivotal Phase III GRID (GIST - Regorafenib In Progressive Disease) trial that demonstrated a statistically significant improvement in progression-free survival or PFS compared to placebo in patients with GIST whose disease had progressed after treatment with imatinib mesylate and sunitinib malate.

Stivarga is approved in several countries, including the USA and Japan, for the treatment of patients with metastatic colorectal cancer or mCRC. Stivarga was recommended for approval by the European Committee for Medicinal Products for Human Use or CHMP for the treatment of adults with mCRC on June 27, 2013. The company noted that the decision of the European Commission on the marketing authorization is expected later in 2013.

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.

Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression - angiogenesis, oncogenesis and the tumor microenvironment.

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