US FDA approves Genentech/Roche's Herceptin for HER2-positive metastatic stomach cancer; Roche amends deal with Biogen

US biotech giant Genentech, part of Swiss drug major Roche (ROG: VX), says the US Food and Drug Administration has approved its already-marketed cancer drug Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic (cancer that has spread) cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.

Separately, Roche and USA-based Biogen Idec () agreed to amend their collaboration on antibodies targeting CD20. Under the amendment, Genentech will assume responsibility for further development and commercialization of ocrelizumab in multiple sclerosis, and will fund 100% of the costs going forward. Biogen will be eligible to receive tiered, double-digit royalties on US sales of ocrelizumab.

Furthermore, Biogen Idec agreed to increase its share of the losses and profits related to the development and commercialization of GA101 for CLL and NHL in the US to 35% from previous 30% share. As a result of this commitment, Biogen Idec will now pay Genentech about $10 million as a catch-up payment for expenses incurred to date on GA101.