Bayer Healthcare announced it had received regulatory approval to market its cancer drug Stivarga in Japan. Bayer Healthcare is a subsidiary of Bayer AG, Germany's largest drug manufacturer. The Ministry of Health, Labor and Welfare of Japan (MHLW) gave Bayer the green light to market Stivarga to treat patients suffering from gastrointestinal stromal tumor (GIST). The treatment would be catered for those whose conditions had progressed after systemic cancer therapy had already been given.
The Japanese regulator gave its approval after positive results were obtained from the third phase of the GRID (GIST-Regorafenib in Progressive Disease) trial. The tests were able to demonstrate significant improvement in GIST patients treated with the drug compared to those who were administered with placebos.
Stivarga has also been approved for the treatment of adults with metastatic colorectal cancer (mCRC) in the US, Japan and other countries. This was upon the recommendation given by the European Committee for Medicinal Products for Human Use given last June. Bayer said it expected to receive a marketing authorization from the European Commission later this year.
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