- In June, the Committee for Medicinal Human Products (CMHP) recommended that the EMA approve Roche’s Avastin for use in recurrent ovarian cancer.
- Avastin was approved in Europe as a first-line treatment in women with advanced ovarian cancer after surgery in January 2012 .
- Avastin is still not approved for the treatment of recurrent ovarian cancer in the US, though many physicians are prescribing it off label.
Avastin continues to be a top-selling drug, with sales of $3.4 billion for the first half of the year. Approval for the treatment of recurrent ovarian cancer is considered a breakthrough because ovarian cancer can be especially hard to treat. In fact, it causes more deaths than any other gynecologic cancer.
Analysts estimate that the new indication could add $1 billion in sales. Not only has Avastin not been approved in the US, but in 2011 Avastin’s breast cancer indication was openly questioned when data emerged suggesting it was not effective. Around the same time, its uses for breast cancer patients was limited in the EU, resulting in a $1 billion loss. Avastin has now become the first biologic approved in the EU for the treatment of ovarian cancer. Approval in the US is still a possibility, but regulators would like to see stronger data.