Switzerland-based Roche has received approval from the European Commission for its Avastin (bevacizumab) in combination with standard chemotherapy to treat adult patients with persistent, recurrent or metastatic carcinoma of the cervix.
Approval has been granted in combination with standard chemotherapy, including paclitaxel and cisplatin or alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy to treat an advanced cervical cancer.
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Roche global product development head and chief medical officer 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."
Approval was based on results of the pivotal GOG-0240 study, which demonstrated that women who received Avastin plus chemotherapy had a statistically significant 26% reduction in the risk of death compared against women who received chemotherapy alone.
GOG-0240 is an independent and National Cancer Institute (NCI)-sponsored study of the Gynecological Oncology Group (GOG) that evaluated the efficacy and safety profile of Avastin plus chemotherapy in women with persistent, recurrent or metastatic carcinoma of the cervix.
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By GlobalDataIn August 2014, Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan chemotherapy received approval in the US, based on the same GOG-0240 data.
The same combination also received approval in Switzerland in December 2014 and in six other countries to treat women with persistent, recurrent or metastatic carcinoma of the cervix.
Avastin initially received approval in the US in 2004 to treat colorectal cancer and is also approved in Europe to treat advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer.
Image: Cervical cancer seen on a T2 weighted saggital MR image of the pelvis. Photo: courtesy of Rádiológ.
