On 25 September 2024, MSD announced that Japan’s Ministry of Health, Labour and Welfare approved its Keytruda® (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy, for patients with non-small cell lung carcinoma (NSCLC). This NSCLC indication approval is based on results from the Phase 3 KEYNOTE-671 trial and follows approvals for the same indication in the EU (March 2024) and US (October 2023).
On the same date, MSD announced that Keytruda® has also been approved in Japan as monotherapy for patients with radically unresectable urothelial carcinoma who are not eligible for any platinum-containing chemotherapy and, in combination with Astellas’ Padcev® (enfortumab verdotin-ejfv), for first-line treatment of radically unresectable urothelial carcinoma. These approvals were based on results of the Phase 2 KEYNOTE-052 and Phase 3 KEYNOTE-A39 trials, respectively.
The Padcev®/Keytruda® combination was approved in Europe earlier this month as first-line treatment for unresectable or metastatic urothelial cancer and in the US in December 2023 for the same indication. Padcev®, an antibody drug conjugate, is co-developed by Astellas and Pfizer under a global development and commercialisation collaboration.