FDA Approval Alert: Expanded Indication for Gastric Cancer Therapy
The US Food and Drug Administration (FDA) expanded the approval of a targeted therapy to treat gastric or gastroesophageal junction (GEJ) cancer.
Pembrolizumab (Keytruda, Merck) is now indicated for patients with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma. Patients eligible for pembrolizumab therapy under this new indication must have PD-L1-expressing tumors, and must demonstrate disease progression after two or more prior lines of therapy – including fluoropyrimidine- and platinum-containing chemotherapy and, in some cases, HER2/neu-targeted therapy.
The new indication came following an accelerated approval designation based on tumor response rate and durability of response. Continued approval for this indication is contingent on verification of clinical benefit in the confirmatory trials.
Adverse events associated with pembrolizumab include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and skin reactions.
“Keytruda is now the first PD-1 checkpoint inhibitor approved in the United States for previously treated advanced gastric or GEJ cancer, helping to address a recognized treatment gap,” said Roger M Perlmutter, president, Merck Research Laboratories, in a statement (September 24, 2017). “This approval marks another milestone – the tenth new indication for Keytruda in just three years – which further demonstrates both our commitment to patients and the progress we have made in the fight against many cancers.”