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Home Industry News Bayer HealthCare files for EU approval of new GIST therapy

Bayer HealthCare files for EU approval of new GIST therapy

6th September 2013

Bayer HealthCare has applied for European regulatory approval of its oral multi-kinase inhibitor regorafenib for the treatment of patients with gastrointestinal stromal tumours (GlST).

The drug is specified for people who have been previously treated with two tyrosine kinase inhibitors and has demonstrated its potential progression-free survival benefits in a study called Grid.

Regorafenib was approved in Europe for the first time last month as a therapy for metastatic colorectal cancer and is sold under the brand name Stivarga, while it has already been ratified as a GIST treatment in the US and Japan.

Dr Kemal Malik, member of the Bayer HealthCare executive committee and head of global development, said: "The submission of regorafenib to the EMA is an exciting advance, because it means patients with GIST will have a potential new treatment option to help manage an aggressive disease."

The company also recently received EU approval for its drug Eylea to be used for the treatment of visual impairment due to macular oedema secondary to central retinal vein occlusion last month.ADNFCR-8000103-ID-801634425-ADNFCR

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