Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilar Deals 2025
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Helen Macpherson
Intranet
Kimberley Evans
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

New Indication Alert: MSD’s Keytruda® Approved in Japan for NSCLC and Urothelial Carcinoma

Sep 25, 2024

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.