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Keytruda is approved in Japan by PMDA for HER2- negative inoperable breast cancer and for patients with unresectable, advanced or recurrent high microsatellite instability (MSI-H) colorectal cancer.- Merck Inc.,
Merck has announced that Keytruda, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). 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 III 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 III KEYNOTE-177 trial. With these approvals, Keytruda has 15 authorized uses in Japan, including indications in nine tumor types as well as MSI-H tumors.
Condition: Breast Cancer Triple Neg
Type: drug
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