This article is more than 5 years old. Information may no longer be current.
FDA grants priority review to Avastin for advanced cervical cancer
Click Here to Manage Email Alerts
The FDA has granted priority review to bevacizumab plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer, according to a press release issued by the drug’s manufacturer.
The FDA based its decision in part on results of the phase 3 GOG-0240 study, which assessed the efficacy and safety profile of bevacizumab (Avastin, Genentech) plus chemotherapy (paclitaxel/cisplatin or paclitaxel/topotecan) in 452 women with cervical cancer.
Sandra Horning
“This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients.”
According to the release, the study met its primary endpoint of improving OS with a statistically significant 29% reduction in the risk of death for women who received bevacizumab plus chemotherapy compared with those who received chemotherapy alone (median OS: 17 months vs. 13.3 months; HR=0.71; P=.004).
In addition, women who received bevacizumab plus chemotherapy exhibited improved PFS compared with those who received chemotherapy alone (median PFS: 8.2 months vs. 5.9 months; HR=0.67; P=.002).
The most common adverse events associated with bevacizumab were hypertension, gastrointestinal or genitourinary fistulas and thromboembolic events.