FDA granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
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).
