Becomes first biologic to win approval for platinum-sensitive ovarian cancer
Roche's Avastin has become the first biologic drug to be approved for the treatment of women with recurrent, platinum-sensitive ovarian cancer in the EU.
The European Commission gave the go-ahead for Avastin (bevacizumab) to be used alongside standard chemotherapy with carboplatin and gemcitabine in women with first recurrence of platinum-sensitive ovarian cancer.
Roche's drug was approved for use as a first-line therapy for advanced ovarian cancer after surgery in December 2011, but the new use provides an important treatment option for women whose disease returns.
Roche said in its third-quarter results statement that approval in ovarian cancer was one of the growth drivers for the product in the first nine months of 2012, with sales increasing 6 per cent compared the same period of 2011 to reach 4.3bn Swiss francs ($4.6bn).
The latest approval was based on data from the phase III OCEANS study which showed that women with recurrent, platinum-sensitive ovarian cancer who received Avastin in combination with chemotherapy had significantly longer progression-free survival (PFS) compared to those who received chemotherapy alone.
Median PFS in the Avastin group was 12.4 months, versus 8.4 months for those on chemotherapy. The trial was presented at the American Society of Clinical Oncology meeting in 2011, and was applauded as the first phase III trial of an anti-angiogenic therapy to demonstrate a clinical benefit in these patients.
Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide.
Avastin is already approved in the EU for advanced breast cancer, non-small cell lung cancer and kidney cancer. In the US its approval in breast cancer was revoked by the US FDA last year but it remains approved for NSCLC, kidney and colorectal cancers and glioblastoma.
Roche said earlier this year it had no plans to seek approval of Avastin in the US after concluding that data from its studies would not support approval by the FDA in light of its decision on breast cancer.