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news.Swiss drug-maker Roche has received approval from the the European Commission (EC) for Avastin (bevacizumab) in combination with standard chemotherapy to treat adults with persistent, recurrent or metastatic carcinoma of the cervix.
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These standard chemotherapies include paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
The approval was based on data from the pivotal GOG-0240 study, which 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.
Roche chief medical officer and head of Global Product Development Dr Sandra Horning said: "We are pleased that women in Europe now have a much needed new treatment option that is proven to help them live longer lives compared to chemotherapy alone.
"Currently, fewer than one in six women with this disease are alive five years after diagnosis. Avastin’s approval is a welcome advance for women with persistent, recurrent or metastatic carcinoma of the cervix."
Based on the GOG-0240 data, Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan chemotherapy was approved in the US, Switzerland, and six other countries worldwide, for this indication.
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored study of the Gynecological Oncology Group (GOG), which evaluated the efficacy and safety profile of Avastin plus chemotherapy these patients.
A total of 452 women were involved in the trial, which also met its primary endpoint of improving overall survival (OS).