Genentech appeals FDA’s plan to pull Avastin off market
NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.
The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.
The company submitted the data it plans to use for its appeal hearing with the agency, though a date has not been set, the newspaper reported.
The FDA announced on Dec. 16 that it was planning to revoke Avastin’s approval for the indication after it reviewed four clinical studies and concluded that the drug does not prolong patients’ overall survival or slow the disease’s progression enough to outweigh its “significant risk” to patients. In July, the FDA’s Oncologic Drugs Advisory Committee had voted 12-1 to recommend revoking the approval.
Genentech: Advanced skin cancer treatment boosts survival rate
SOUTH SAN FRANCISCO, Calif. — Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.
The company, part of Swiss drug maker Roche, said patients with advanced melanoma containing a mutated version of a protein called BRAF lived longer when receiving the orally administered personalized investigational medicine RG7204 than those receiving the injected chemotherapy drug dacarbazine.
The company said it would present full data from the study at an unspecified medical meeting later this year.
Giant Eagle announces free in-store diabetes screenings
PITTSBURGH — In partnership with Bayer Healthcare Diabetes Care and Novo Nordisk, Giant Eagle is offering its customers free in-store diabetes screenings.
Offerings include A1C tests to measure blood-glucose levels, as well as consultations with Giant Eagle diabetes and pharmaceutical care specialists. The retailer also will have dietitians and wellness coaches on hand at select locations.
Testing is available through Feb. 5, while supplies last.