Roche’s Avastin plus chemotherapy receives positive recommendation from CHMP for EU approval in advanced cervical cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the use of 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 Cervical cancer is most commonly diagnosed in younger women, those between the ages of 35 and 44, and every year over 30,000 women in the EU are diagnosed with the disease.^2,3

“Treatment options in Europe for women whose cervical cancer has recurred, persisted or spread are currently limited to chemotherapy,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “This CHMP positive opinion for Avastin brings us one step closer to providing women with a much needed, new treatment option that can help them live longer compared to chemotherapy alone.”

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; Hazard Ratio (HR)=0.74, p=0.0132).¹

In August 2014 in the U.S., 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.

References

1. Roche data on file
2. National Cancer Institute. Surveillance, Epidemiology and End Results program (SEER) Stat Fact Sheets: Cervix Uteri Cancer. Last accessed February 2015 at http://seer.cancer.gov/statfacts/html/cervix.html
3. European Cancer Observatory: Cancer Incidence, Mortality, Prevalence and Survival in Europe. Cervical cancer. Last accessed February 2015 at http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=25&Gender=2