FDA Restricts Use of Immunotherapies in Gastric, Esophageal Cancers

FDA Restricts Use of Immunotherapies in Gastric, Esophageal Cancers

(MedPage Today) -- The FDA narrowed the indications for pembrolizumab (Keytruda) and nivolumab (Opdivo) in gastric, gastroesophageal junction (GEJ), and esophageal cancers, according to letters sent to the respective drugmakers. The agency had...

FDA Puts New Stomach Cancer Restrictions in Place for Keytruda, Opdivo

Recommendations made by a scientific advisory panel last year have been embraced by federal regulators. Federal drug regulators have decided to place new limits on the use of autoimmune medications for stomach cancer, after scientific experts determined there is insufficient evidence to prove they are effective. Late last month, the U.S. Food and Drug Adminis…

FDA adds biomarker limits to stomach, esophageal cancer labels for Merck's Keytruda and BMS' Opdivo

The FDA late last month sent letters to Merck and Bristol Myers Squibb telling them that their blockbuster cancer drugs Keytruda and Opdivo should be limited to metastatic gastric, gastroesophageal junction and esophageal cancer in ...