Bayer and Onyx' Stivarga cleared in Europe

In a second piece of good news within a couple of days for German drug major Bayer (BAYN: DE), the European Commission has approved Stivarga (regorafenib) tablets for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously been treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine based chemotherapy, an anti VEGF therapy and an anti EGFR therapy.

Stivarga, which is partnered with USA-based Onyx Pharmaceuticals (Nasdaq: ONXX), is approved for the treatment of patients with mCRC and gastrointestinal stromal tumors (GIST) in several countries, including the USA and Japan. Onyx co-promotes the drug in the USA and receives a royalty on all global net sales of Stivarga in oncology. Bayer also received European clearance for extended use of its ophthalmic drug Eylea (aflibercept; The Pharma Letter August 29).

Stivarga, which has been touted as having a $1 billion plus sales potential, is still rolling out but has already generated sales of 87 million euros ($116.6 million) in the first half of the current year.