26 August 2021 - Keytruda now approved for the treatment of patients with PD-L1 positive, hormone receptor negative and HER2 negative, inoperable or recurrent breast cancer.

Merck today announced that Keytruda, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency. 

Keytruda is approved for the treatment of patients with PD-L1 positive, hormone receptor negative and human epidermal growth factor receptor 2 (HER2) negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial.

Additionally, Keytruda as a monotherapy is approved for the treatment of patients with unresectable, advanced or recurrent high microsatellite instability (MSI-H) colorectal cancer, based on results of the Phase 3 KEYNOTE-177 trial. 

With these approvals, Keytruda has 15 authorised uses in Japan, including indications in nine tumour types as well as MSI-H tumours.

Read Merck press release