Merck: FDA approves Keytruda for solid tumors
(CercleFinance.com) - Merck announced that the US FDA has granted full approval of Keytruda for the treatment of patients (adults and children) with unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair (dMMR) in solid tumors, for who have no satisfactory treatment options or alternatives.
The conversion from accelerated to full approval is based on results from Phase 2 trials involving 504 patients in more than 30 cancer types. This is the first full approval of an immunotherapy based on a predictive biomarker, regardless of solid tumour type, the company said.
"This approval reinforces the important role of Keytruda in certain patients with MSI-Hor dMMR solid tumours against a variety of cancers, a related source said.
Copyright (c) 2023 CercleFinance.com. All rights reserved.
The conversion from accelerated to full approval is based on results from Phase 2 trials involving 504 patients in more than 30 cancer types. This is the first full approval of an immunotherapy based on a predictive biomarker, regardless of solid tumour type, the company said.
"This approval reinforces the important role of Keytruda in certain patients with MSI-Hor dMMR solid tumours against a variety of cancers, a related source said.
Copyright (c) 2023 CercleFinance.com. All rights reserved.