Merck & Co scores European and US wins for Keytruda0 SHARESPosted: 22 September 2025 | Dominic Tyer (European Pharmaceutical Review) |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. Since then it has added indications that include non‑small cell lung carcinoma, renal cell carcinoma and colorectal cancer. Meanwhile, Merck & Co recently received another boost for Keytruda after the cancer drug won a new US approval from the US 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.