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Bayer GIST drug wins US orphan status

Bayer has been granted orphan status by the US Food and Drug Administration for an investigational treatment for gastrointestinal stromal tumours

Bayer HealthCare Pharmaceuticals has been granted orphan status by the US Food and Drug Administration (FDA) for an investigational treatment for gastrointestinal stromal tumours (GIST), the most common form of sarcoma involving the GI tract.

The drug, known as regorafenib (BAY 73-4506), is currently being studied in a phase III trial that began enrolment last month. The study is comparing regorafenib, plus best supportive care, to placebo, plus best supportive care, for subjects with metastatic and/or unresectable GIST whose disease has progressed despite prior treatment.

The primary endpoint is progression-free survival, while secondary endpoints include overall survival, time to progression, disease control rate, tumour response rate, duration of response, and safety. Bayer expects to enrol 170 patients in the study.

Orphan status, which is designed to encourage the development of drugs for diseases that affect fewer than 200,000 Americans, confers a number of potential benefits, including research funding, tax breaks, and seven years of US marketing exclusivity. There are about 4,500 to 6,000 new cases of GIST diagnosed annually in the US, according to Bayer.

Regorafenib, which Bayer is also testing for a number of other kinds of cancer, is a follow-on product to Nexavar (sorafenib), a marketed cancer drug that it developed in partnership with the biotech company Onyx. Both drugs are multikinase inhibitors that work by blocking the growth of the blood vessels that feed tumours.

Onyx filed a lawsuit against Bayer in 2009 arguing that the new drug is nearly identical to Nexavar, but Bayer has continued with development of the drug while the legal matter is pending.

7th February 2011

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