The latest development comes after the EMA CHMP provided a positive opinion recommending a grant of approval for the Keytruda regimen. Credit: Copyright © 2023 Merck & Co., Inc., Rahway, NJ USA, and its affiliates.

The European Commission (EC) has granted approval for Merck’s (MSD) Keytruda plus trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The combination treatment is indicated as a first-line therapy for adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive GEJ adenocarcinoma, with tumours expressing PD-L1.

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An anti-programmed death receptor-1 (PD-1) therapy, Keytruda became the first immunotherapy to receive approval in the EU as the first-line therapy option for this patient population.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended a grant of approval for the treatment in July 2023. 

The Keytruda regimen will be marketed in all 27 member states of the European Union but will not be available in Norway, Northern Ireland, Iceland or Lichtenstein.

The regulator approved the treatment based on the findings from the double-blind, randomised Phase III KEYNOTE-811 clinical trial. The Keytruda combination substantially enhanced progression-free survival and objective response rate versus trastuzumab and chemotherapy alone.

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Merck Research Laboratories global clinical development vice-president Dr Scot Ebbinghaus stated: “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 the approval of Keytruda, we’re proud that patients whose tumours express PD-L1 with a combined positive score greater than or equal to one and healthcare providers in the EU will have an option that includes immunotherapy for this difficult-to-treat disease.”

In April 2023, the US Food and Drug Administration accepted for review MSD’s new supplemental biologics licence application for the Keytruda regimen to treat gastric cancer.