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Roche gets EMA positive recommendation for Avastin plus chemotherapy to treat cervical cancer

Roche has received positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the use of Avastin (bevacizumab) in combination with standard chemotherapy to treat adults with persistent, recurrent or metastatic cervical cancer.

Standard chemotherapy includes paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan for patients who cannot receive platinum therapy.

Cervical cancer is most commonly diagnosed in women aged between 35 and 44, and more than 30,000 women in the EU are diagnosed with the disease every year.

Roche chief medical officer and head of Global Product Development Dr Sandra Horning said: "Treatment options in Europe for women whose cervical cancer has recurred, persisted or spread are currently limited to chemotherapy.

"This CHMP positive opinion for Avastin brings us one step closer to providing women with a much needed, new treatment option that can help them live longer compared to chemotherapy alone."

The positive recommendation was based on the significant survival benefit in the pivotal GOG-0240 trial that evaluated the efficacy and safety profile of Avastin plus chemotherapy in 452 women with persistent, recurrent or metastatic cervical cancer.

The trial showed that women who received Avastin plus chemotherapy had a statistically significant 26% reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone.