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News
Japan's Ministry of Health, Labor and Welfare has approved a subcutaneous formulation of pembrolizumab (Keytruda) for all cancer indications where the IV version is already approved. The injection takes as little as 1 minute — compared to a 30-minute IV infusion — and showed comparable efficacy and safety in a phase 3 trial. Japan joins the US and EU in clearing this more convenient delivery option.
Japan's Ministry of Health, Labor and Welfare has approved subcutaneous pembrolizumab and berahyaluronidase alfa (Keytruda Qlex/Keyject) across all cancer indications for which IV Keytruda is currently approved in the country. The new formulation can be administered in as little as 1 minute every 3 weeks or 2 minutes every 6 weeks — a significant time-saver compared to the standard ~30-minute IV infusion.
The approval was supported by the phase 3 3475A-D77 trial, which enrolled 377 patients with treatment-naive metastatic non-small cell lung cancer (NSCLC). The study confirmed that the subcutaneous formulation delivered noninferior drug exposure versus IV, with comparable response rates, progression-free survival, and safety profiles. Injection-site reactions were rare and mild.
By the Numbers:
Why it matters: This approval makes Japan the third major regulatory region — after the US (September 2025) and EU (November 2025) — to clear subcutaneous pembrolizumab. A faster, simpler administration route could meaningfully reduce clinic time, ease infusion center burden, and improve the overall treatment experience for patients.
