Overview

• Regulators cleared the under‑the‑skin version for adults across most solid‑tumor indications, covering 38 labeled uses.
• The injection can be given in about one minute every three weeks or two minutes every six weeks, compared with a roughly 30‑minute IV infusion.
• A Phase 3 study in first‑line metastatic non‑small cell lung cancer found similar response rates and no notable differences in progression‑free or overall survival versus IV Keytruda.
• Merck expects U.S. availability in late September and says pricing will be similar to the IV form, with final details to follow.
• Industry analysts project partial switching, estimating roughly 30%–40% uptake within two years, but they see limited protection against biosimilars and IV‑dependent combination regimens after 2028.