EU approves Roche’s Avastin plus chemotherapy for women with advanced cervical cancer
Posted: 8 April 2015 |
The EU has approved Avastin in combination with chemotherapy for the treatment of persistent, recurrent or metastatic carcinoma of the cervix…
Roche has announced that the European Commission (EU) has approved Avastin (bevacizumab) in combination with standard chemotherapy for the treatment of adult patients with persistent, recurrent or metastatic carcinoma of the cervix.
Unlike the majority of cancers, cervical cancer is most commonly diagnosed in younger women, between the ages of 35 and 44.Each day it is estimated that 90 women are diagnosed with cervical cancer in Europe, and around 35 of these women will die from the disease. Avastin’s EU approval in persistent, recurrent or metastatic carcinoma of the cervix is an important development in a disease area where, until now, treatment options were limited to chemotherapy.
Avastin’s EU approval is an important development in a disease area where treatment options have been limited to chemotherapy
“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,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “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”.
The EU approval 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; Hazard Ratio (HR)=0.74, p=0.0132).
Also based on the GOG-0240 data, Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan chemotherapy was approved in the U.S. in August 2014, in Switzerland in December 2014, and in six other countries worldwide, for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix.
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