FDA thumbs up for expanded ovarian cancer indication for Avastin

The US Food and Drug Administration has approved Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

Avastin, developed by Genentech, a subsidiary of Swiss pharma major Roche’s (ROG: SIX), is already a mega blockbuster cancer drug in its current indications, with 2015 sales of 6.68 billion Swiss francs ($7.67 billion). This latest decision means that Avastin is now cleared in the USA for nine distinct uses across six different types of cancer.

“With today’s approval of Avastin plus chemotherapy, women in the US with recurrent, platinum-sensitive ovarian cancer now have a treatment option that showed a survival difference of more than five months compared to chemotherapy alone in a clinical trial,” said Sandra Horning, chief medical officer and head of global product development. “This approval was based in part on a Gynecologic Oncology Group cooperative clinical trial and reinforces the importance of partnerships with study groups to identify new treatment options for people in need,” she noted.