On 18 September 2024, Merck (known as MSD outside the US and Canada) announced that Keytruda® (pembrolizumab) has been approved by the FDA, in combination with pemetrexed and platinum chemotherapy, for first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). MSD’s sBLA for this indication of was accepted for priority review by the FDA in May 2024, with a target action date of 25 September 2024.
MSD currently has an application before Australia’s TGA for the same MPM indication expansion for Keytruda®.
The new US indication follows Keytruda®’s FDA approval in June 2024 (in combination with carboplatin and paclitaxel) for primary advanced or recurrent endometrial carcinoma.