EU backs Roche's Avastin for hard-to-treat ovarian cancer

Avastin was first approved to treat colon cancer a decade ago, but as Roche's ($RHHBY) blockbuster drug continues to prove effective in treating other forms of the disease, the company keeps submitting if for new uses--and succeeding. Today the EU Committee for Medicinal Products for Human Use (CHMP) handed down a positive ruling on Avastin, recommending that the European Commission approve the drug for use in women with ovarian cancer that's resistant to platinum-based chemotherapy. It's the first biologic to receive a positive opinion from the CHMP for this hard-to-treat form of the disease.

About 230,000 women are diagnosed with ovarian cancer worldwide, according to data compiled by Roche. About 60,000 women who relapse are resistant to platinum-based treatments, and the median overall survival rate for these patients is only a year, the company reports.

"Women with platinum-resistant ovarian cancer have limited medicines available for their difficult disease," said Sandra Horning, chief medical officer and head of global product development for Roche in a press release. She added that the approval "would be an important step in helping these women live longer without their disease progressing."

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. The Commission is expected to make a final decision in the coming months.

The positive ruling comes just one year after Avastin got a major snub from the U.K.'s cost-effectiveness watchdog, the National Institute for Health and Care Excellence (NICE), which recommended against prescribing the drug in combination with chemo for advanced recurring ovarian cancer. As is usually the case with such rejections, NICE cited a lack of evidence that the benefits of Avastin outweigh its cost, which was estimated to be £25,000 ($42,565) per course at the time.

NICE has actually rejected Avastin for 5 separate uses, but that hasn't stopped British physicians from prescribing it. In fact, it is one of the most widely prescribed drugs in the U.K. Avastin is already approved in Europe to treat other forms of ovarian cancer, and the indication helped push Roche's first-quarter sales up 5% year-over-year in constant currencies to 11.5 billion Swiss francs ($13 billion).

As Avastin continues to rack up new approvals, its sales just keep on climbing. The drug--which chokes off the blood supply to tumors--was one of the world's best selling cancer drugs of 2013, pulling in sales of $6.75 billion. Avastin is already approved to treat some forms of brain cancer, and the company is testing it in patients with glioblastoma, a type of brain tumor that's particularly tough to treat. In fact, CHMP noted that Roche is asking it to reconsider a negative ruling from last month of the use of Avastin for treating glioblastoma. Roche also is testing the drug in combination with its anti-PDL1 therapy MPDL3280A, a combo that one the coveted "breakthrough" designation from the FDA last month.

- here's the press release
- Get more at PharmaTimes
Here's PMLive's take

Special Report: Top 10 best-selling cancer drugs of 2013 – Avastin

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