SOUTH SAN FRANCISCO, Calif. Biotech company Genentech has amended its application to the Food and Drug Administration seeking an additional approval for one of its drugs, which the FDA has deemed a “major amendment,” Genentech said Monday.
Genentech, part of Swiss drug maker Roche, is seeking approval for Avastin (bevacizumab) combined with paclitaxel chemotherapy for untreated advanced breast cancer without the HER2 protein. The FDA has granted accelerated approval to Genentech’s application, and the company expects the agency to take action by Dec. 17. The expected action date is based on the FDA’s decision to extend its review period in light of the amendment.
“We are pleased by the FDA’s decision to review additional information on Avastin and are committed to working with the agency during this extended review period,” Genentech EVP product development and chief medical officer Hal Barron said.
Avastin already is approved for treating cancers of the colon and rectum, lungs and kidneys.