FDA’s cancer czar Richard Pazdur had a “silver anniversary” at the agency recently. So, he invited some guests—the commissioners he had reported to under the Democratic and Republican administrations.
FDA granted traditional approval to Merck’s pembrolizumab (Keytruda) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (CPS ≥1).
