On 28 November 2025, Australia’s TGA updated its online list of prescription medicines for evaluation for the months of September, October and November. Among the new inclusions is an indication extension for MSD’s Keytruda® (pembrolizumab) in combination with paclitaxel and/or bevacizumab to help treat certain types of ovarian, fallopian tube, or peritoneal cancer for people whose cancer has not responded to platinum-based medicines and who have already tried one or two other treatments.
This follows another indication extension application for Keytruda® accepted by the TGA in March 2025 for patients with head and neck squamous cell carcinoma (HNSCC) as a preliminary treatment prior to surgery or as a treatment in combination with radiotherapy followed by Keytruda® alone. That application is still under consideration.
The HNSCC indication application was accepted by the US FDA in June 2025, and regulatory authorities in Brazil, Canada, Israel and Switzerland are also reviewing the application.