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Pharmaceuticals / Submissions and Approvals

FDA Approves Avastin for Aggressive, Late-Stage Cervical Cancer Treatment

Aug. 25, 2014

Roche got the greenlight to market its blockbuster cancer drug Avastin for the treatment of advanced cervical cancer, making it the first biologic drug approved in combination with chemotherapy for the disease.

The FDA approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic cervical cancer, the company said.

The drug was approved in less than four months under the FDA’s priority review program, said Richard Pazdur, director of the agency’s Office of Hematology and Oncology.
It is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin, Pazdur said.

This is Avastin’s fifth approved indication. The drug was first approved in the U.S. in 2004 for the treatment of advanced colorectal cancer. It has since been approved to treat non-small cell lung cancer, metastatic breast cancer, kidney cancer and progressive glioblastoma.

However, in November 2011 the FDA withdrew the drug’s breast cancer indication due to lack of evidence that it helped patients live longer.

In Europe, Avastin is approved for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer and kidney cancer. Earlier this month, the European Medicines Agency approved Avastin in combination with chemotherapy to treat recurring ovarian cancer that is resistant to platinum-containing chemotherapy. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.