Another voluntary withdrawal for Keytruda, in gastric cancer

2 July 2021

New Jersey-based drugmaker Merck & Co (NYSE: MRK) is to voluntarily withdraw an Accelerated Approval indication for Keytruda (pembrolizumab) in the USA.

Following discussion with the US Food and Drug Administration, Merck has agreed to restrict the label for the blockbuster immuno-oncology product, excluding a previously awarded nod for the treatment of certain people with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Keytruda revenues for just the first quarter of 2021 came in at $3.9 billion, up 19% from the same period last year.

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