After promising last month to fast track its review of Roche's ($RHHBY) Avastin in cervical cancer, the FDA has come back with a positive verdict--a full two months before its deadline. The agency approved the blockbuster drug to be used in combination with chemotherapy in women with advanced cervical cancer.
Avastin is the first biologic for late-stage cervical cancer ever to be approved by the FDA, and the first new treatment for the disease to hit the market since 2006, according to a statement from the agency. The American Cancer Society estimates that more than 12,000 new cases of cervical cancer will be diagnosed in the United States in 2014 and about 4,000 women will die from the disease, according to a Roche press release.
"Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread," said Sandra Horning, Roche's chief medical officer and head of global product development.
The approval was based on a National Cancer Institute-sponsored study of 452 women that showed a 26% reduction in the risk of death for women who received Avastin plus chemotherapy compared with those who received chemotherapy alone, according to Roche's statement. It is the fifth FDA nod for Avastin, which was first approved in 2004 for colorectal cancer and has since been approved to treat glioblastoma, non-small cell lung cancer and kidney cancer.
Analysts have not yet estimated how the new Avastin approvals will impact Roche's top line, but the drug has already been a workhorse for the company of late. With $6.75 billion in sales in 2013, Avastin was the year's second-best-selling oncology treatment, and one of the 10 best-selling drugs overall, according to FiercePharma research. And in its most recent earnings release, Roche said the drug helped push its first-half sales up 5% to nearly 23 billion Swiss francs ($25.4 billion).
And there could be more good news for Avastin soon. The Committee for Medicinal Products for Human Use (CHMP) in Europe recommended in June that Avastin be approved there for advanced ovarian cancer. In July, the FDA fast-tracked its review of the drug to treat advanced ovarian cancer that's resistant to standard chemotherapy. The company is expecting an answer by Nov. 17.
- here's Roche's announcement
- read the FDA's statement
Special Report: Top 10 best-selling cancer drugs of 2013 - Avastin