The US Food and Drug Administration has Expanded the Approval of the Precision Cancer Medicine Keytruda for Treatment of Gastric Cancer
Keytruda (Pembrolizumab) is now indicated for patients with recurrent locally advanced or metastatic gastric or gastro-esophogeal junction adenocarcinoma. Patients eligible for keytruda 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.
Keytruda is a monoclonal antibody that helps to restore the body’s immune system in fighting cancer. It creates its anti-cancer effects by blocking a specific protein used by cancer cells called PD-L1, to escape an attack by the immune system. Once PD-L1 is blocked, cells of the immune system are able to identify cancer cells as a threat, and initiate an attack to destroy the cancer. Keytruda is also approved for the treatment of certain types of metastatic melanoma, lung, and head and neck cancer.
The new indication for treatment of gastric and gastric esophageal junction cancers 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.
“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.”
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