Roche’s Avastin set for new ovarian cancer indication in Europe
pharmafile | September 26, 2011 | News story | Sales and Marketing | avastin, ovarian cancer
Roche’s Avastin has gained the backing of European regulatory advisors for a new indication in ovarian cancer.
The European Medicines Agency’s CHMP has supported the use of Avastin (bevacizumab) in combination with carboplatin and paclitaxel for advanced epithelial ovarian, primary peritoneal or fallopian tube carcinoma.
There are currently few treatments outside of chemotherapy and surgery for this type of cancer and if licensed, Avastin will be the first targeted drug approved to treat the disease.
The CHMP’s positive opinion is based on recent data in which patients receiving Avastin, in combination with chemotherapy (paclitaxel and carboplatin) – and then with continued use on its own for up to 15 months – showed a median progression-free survival (PFS) of 14.1 months.
This compared to 10.3 months in women who received chemotherapy alone – a 28% reduction in the risk of cancer progression or death.
Hal Barron, head of global product development, said: “The positive CHMP opinion is great news for women with advanced ovarian cancer, who need more effective treatment options.
“Approval of Avastin would be a major development in this setting where few treatment advances have been seen in over a decade.”
Avastin is administered for six cycles of treatment followed by continued use of Avastin as a monotherapy until disease progression, or for a maximum of 15 months.
The recommended dose of Avastin is 15 mg/kg of body weight given once every three weeks as an intravenous infusion.
Pharmafocus understands that six doses of the drug given at three-weekly intervals for an average 65kg woman will cost about £14,000 per patient.
Roche’s blockbuster cancer drug is already licensed to treat cancers of the brain, lung, kidney, colon, and breast.
But the $6.5 billion franchise has suffered over the past year after the FDA pulled its breast cancer licence in the US, with the EMA restricting its use with just one form of chemotherapy in Europe.
Analysts believe this will wipe around $1 billion from the franchise, but gaining a new licence in ovarian cancer could help offset this loss.
Roche said that it expected final approval from the European Commission later this year.
Ben Adams
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