Merck & Co scores European and US wins for Keytruda
Posted: 22 September 2025 | Dominic Tyer (European Pharmaceutical Review) | No comments yet
The CHMP hands the cancer drug two new recommendations, and the FDA approves its subcutaneous use as Keytruda Qlex.
Merck & Co’s blockbuster cancer drug Keytruda (pembrolizumab) has been recommended for use in a subcutaneous formulation by European regulatory advisors.
The positive opinion from the Committee for Human Medical Products (CHMP) backs the treatment’s injectable use in all its adult indications approved in the European Union.
That treatment range is set to soon include one more indication, with the CHMP’s latest meeting also backing Keytruda’s use in earlier-stage head and neck cancer.
Dr Marjorie Green, Senior VP and Head of Oncology, Global Clinical Development at Merck Research Laboratories, said: “This is a significant step forward in our pursuit of bringing this therapy to more patients.
“If approved, we believe Keytruda SC has the potential to provide meaningful benefits to patients and providers in Europe because it can offer a shorter administration time compared to Keytruda and the option to receive treatment in additional health care settings.”
Merck & Co, known as MSD outside the US and Canada, first received European and US Keytruda approvals in 2015 and 2014 respectively as an intravenous injection for melanoma Since then it has added indications that include non‑small cell lung carcinoma, renal cell carcinoma and colorectal cancer.
Keytuda’s recommendation for its latest indication came on the back of the phase III Keynote-689 clinical trial in adults with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
European regulators typically follow the CHMP’s lead in their deliberations and final decisions on Keytruda’s new formulation and indication are expected before the end of the year.
Meanwhile, Merck & Co recently received another boost for Keytuda after the cancer drug won a new US approval from the Food and Drug Administration (FDA).
The stateside regulator licensed Keytruda Qlex, which combines pembrolizumab with Alteogen’s berahyaluronidase alfa-pmph, for subcutaneous administration in adults across 38 of Keytruda’s solid tumour indications.
