FDA fast-tracks review of Avastin as supplemental cancer drug
- The FDA is reviewing Avastin (bevacizumab) plus chemotherapy as a treatment for metastatic cervical cancer under fast-track, priority review provisions.
- Avastin is already FDA-approved for various cancer-related treatments, including metastatic colorectal cancer, non-squamous, non-small cell lung cancer and renal cell carcinoma.
- An FDA decision is expected in October.
Roche’s Avastin grossed almost $6.75 billion last year. If approved for treatment of cervical cancer (in conjunction with chemotherapy), Avastin could break the $10 billion a year mark. The phase III data, which compared treatment with Avastin plus chemotherapy in women with metastatic, persistent or recurrent cervical cancer to treatment with chemotherapy alone, showed a significant treatment-related survival advantage.
Adding Avastin to chemotherapy decreased risk of death by 29% (17 months versus 13.3 months) and improved progression-free survival (8.2 months versus 5.9 months). “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,” said Sandra Horning, Roche's chief medical officer.
The forthcoming FDA decision will have an impact on the 12,000 women diagnosed each year with cervical cancer in the US.
- pharmafile.com FDA speedy review for new Avastin licence