Gastric Cancer | Clinical

FDA Approves 1L Pembrolizumab Combination in Locally Advanced Unresectable or Metastatic HER2+ Gastric/GEJ Cancers

May 05, 2021

The FDA has granted accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction cancer.

FDA’s ODAC Votes Against Continuation of Pembrolizumab Third-Line Indication in Gastric/GEJ Cancer

April 29, 2021

The FDA’s Oncologic Drugs Advisory Committee has voted 6 to 2 against the continued approval of pembrolizumab as indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 who experienced disease progression on or after 2 or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2-targeted therapy.