Godkänd indikation för Avastin för behandling av cervixcancer

Basel, 08 April 2015

EU approves Roche’s Avastin plus chemotherapy for women with advanced cervical cancer

Avastin is the first treatment in nearly a decade to extend the life of women with this advanced disease

Roche (SIX: RO, ROG, OTCQX, RHHBY) announced today that the European Commission (EU) approved Avastin (bevacizumab) 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.1

Unlike the majority of cancers, cervical cancer is most commonly diagnosed in younger women, between the ages of 35 and 44.2 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.3 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.

“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).1

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.

About the GOG-0240 study

GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored study of the Gynecological Oncology Group (GOG) that assessed the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with persistent, recurrent or metastatic carcinoma of the cervix.

Study data from 452 women showed:

The study met its primary endpoint of improving overall survival (OS) with a statistically significant 26 percent reduction in the risk of death, representing a median gain in survival of 3.9 months, compared with those who received chemotherapy alone (median overall survival: 16.8 months vs. 12.9 months; (HR)=0.74, p=0.0132).1
The study showed that women who received Avastin plus chemotherapy had a significantly higher rate of tumour shrinkage (objective response rate, ORR) compared with those who received chemotherapy alone (45 percent [95% CI: 0.39%-0.52%] vs. 34 percent [95% CI 0.28%-0.40%]).1
Overall, the safety profile in the study was consistent with that seen in previous pivotal studies of Avastin across tumour types, except for an increase in gastrointestinal-vaginal fistulae observed in patients who received Avastin plus chemotherapy compared to those who received chemotherapy alone (8.3% vs. 0.9% respectively). All patients with gastrointestinal-vaginal fistulae after treatment with Avastin plus chemotherapy had a history of prior pelvic radiation.1