Last week, it was priority review for cervical cancer. This week, it's the fast track for difficult-to-treat ovarian cancer. That's the record for Roche's ($RHHBY) Avastin, which is now up for quick FDA approval of two new indications.
The potential nod in ovarian cancer covers patients who've failed on platinum-based chemotherapy and see their cancer return. It's a particularly stubborn type of ovarian cancer, which is already tough to overcome because it's typically diagnosed in later stages.
"The majority of women with ovarian cancer will become resistant to platinum therapy and a quarter of women will have platinum-resistant disease at the time of a first recurrence," said Sandra Horning, CMO and head of global product development for Roche's Genentech unit. "New treatment options are needed."
The FDA priority review status comes after European regulators gave a preliminary thumbs up for Avastin in the same group of patients. The Committee for Medicinal Products for Human Use (CHMP) backed the drug in June for the new indication, with a European Medicines Agency decision to follow.
The CHMP's opinion was based on results from a Phase III trial of women with recurrent platinum-resistant ovarian cancer, according to Roche. Results showed that adding Avastin to chemotherapy doubled the median progression-free survival rate from 3.4 months to 6.7 months.
It hasn't been all good news for Roche in ovarian cancer, though. Last year, the U.K.'s cost-effectiveness watchdog snubbed Avastin for advanced, recurring ovarian cancer. The National Institute for Health and Care Excellence said there wasn't enough evidence to show that the benefits of Avastin outweigh its cost, estimated at £25,000 ($42,565) per treatment course at the time.
Other recent approvals--expanded use in colorectal cancer in the U.S., and ovarian cancer approval in Europe--helped boost Avastin to $6.75 billion last year, a 13% increase. The drug was 2013's second-best-selling oncology treatment, and among the industry's 10 best-selling products for the year, according to FiercePharma research.
The FDA is set to decide on the new ovarian cancer use by Nov. 17, and the cervical cancer decision is due by Oct. 24.
- read the release from Genentech
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