Merck suffers a setback in Europe over its new Keytruda formulation

Merck has encountered a setback in Europe concerning its newer formulation of Keytruda, the company’s cancer immunotherapy. According to STAT News, a Dutch court has ordered a halt to the manufacturing and marketing of a subcutaneous version of the drug across several European countries.

The ruling, reported October 7, affects the under-the-skin formulation of Keytruda, which differs from the original intravenous version that has anchored Merck’s oncology portfolio for years. STAT News did not detail in the available summary the specific legal basis for the Dutch court’s order, nor which countries beyond the Netherlands are covered by the halt.

The outlet frames the development as a setback for Merck, noting that the court’s action could affect the company’s position in European markets where the subcutaneous formulation had been introduced or planned for rollout. Keytruda, known generically as pembrolizumab, has been one of Merck’s most significant revenue drivers, and formulation changes such as the subcutaneous version are often pursued to extend market exclusivity or improve patient convenience as intravenous infusion schedules face competition from follow-on products.

No further details on the plaintiffs, the specific patent or regulatory dispute at issue, or Merck’s response were included in the available reporting. STAT News indicates the matter remains under its continuing coverage.