Merck’s Keytruda approved by EC for gastric cancer

Betsy Goodfellow | August 30, 2023 | News story | Research and Development EC, Merck, Oncology, gastric cancer, keytruda 

Merck (known as MSD outside of the US and Canada) has announced the approval of its gastric cancer treatment, Keytruda, by the European Commission (EC). The drug will be used in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the treatment of gastric cancer in adults.

The Committee for Medical Products for Human Use (CHMP) gave a recommendation for the approval after the phase 3 KEYNOTE-811 trial, where it was demonstrated that Keytruda increased the rate of survival among patients when combined with trastuzumab and chemotherapy; the results, however, did not meet statistical significance and OS analysis for the trial remains ongoing.

In May 2021, Keytruda was approved by the US Food and Drug Administration (FDA) for the first-line treatment of patients with gastric cancer. The approval of this medication allows marketing in all EU member states, as well as Iceland, Norway, Northern Ireland and Lichtenstein.

Dr Scot Ebbinghaus, vice president of Global Clinical Development at Merck, commented: “Patients in the EU diagnosed with HER2-positive advanced gastric cancer face an aggressive disease associated with a poor prognosis, underscoring the need for additional first-line treatment options for these patients. With today’s approval of Keytruda, we’re proud that patients whose tumours express PD-L1 with a combined positive score ≥1 and healthcare providers in the EU will have an option that includes immunotherapy for this difficult-to-treat disease.”

Merck currently has a clinical development programme evaluating Keytruda’s effectiveness in relation to gastric cancer and is continuing to study other cancer variations it may treat, including hepatobiliary, colorectal and esophageal.

Rebecca Lee

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