CHMP recommends approval of Avastin plus chemo in cervical cancer-Roche

The European Union’s Committee for Medicinal Products for Human Use has issued a positive opinion on the use of Avastin (bevacizumab), from Roche, in combination with standard chemotherapy (paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy) for the treatment of adult patients with persistent, recurrent or metastatic carcinoma of the cervix.

The EU filing was based on the significant survival benefit in the pivotal GOG-0240 study, which showed that women who received Avastin plus chemotherapy had a statistically significant 26 percent reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone (median overall survival: 16.8 months vs. 12.9 months).

Comment: In August 2014 in the USA, and in December 2014 in Switzerland, Avastin was approved in combination with paclitaxel and cisplatin or paclitaxel and topotecan chemotherapy for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix, based on the results of the GOG-0240 study. Patent expiry in the EU is estimated to be January 2022. Patent expiry in the US is estimated to be July 2019.