Keytruda is already treating certain patients with advanced endometrial carcinoma through the tumor-agnostic MSI-H indication, which received accelerated approval four years ago. Merck based its application for the drug on overall response data from Cohorts D and K of the KEYNOTE-158...
Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy...
Food and Drug Administration (FDA) has granted priority review for a supplemental Biologics License Application (sBLA) for KEYTRUDA in combination with concurrent chemoradiotherapy for the treatment of newly diagnosed patients with ...
Merck then received a complete response letter from FDA in March 2021 regarding its supplemental biologics license application, which sought approval for Keytruda based on pathological complete response data and early interim event-free survival findings. In the complete response letter,...
Merck’s anti-PD-1 therapy, Keytruda, has obtained approval from the US Food and Drug Administration (FDA) as an adjuvant therapy for stage IIB or IIC melanoma patients aged 12 years and above. The FDA also expanded the therapy’s indication as adjuvant treatment for stage III melanoma follo...
Merck – known as MSD outside North America – says it will press ahead with filing Keytruda for the new indication later this year, but it will have to chase down a near two-year lead for Roche’s drug. It also has two other studies of Keytruda in TNBC on the go, includ...
“With today’s approval, patients in Japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy.” ...
US regulators have assigned a priority review to MSD’s application to market the immunotherapy Keytruda in combination with chemotherapy as a first-line treatment for squamous non-small cell lung cancer (NSCLC).
RUBY enrolled 494 patients with stage 3 or 4 advanced or recurrent endometrial cancer, 118 of whom had the dMMR/MSI-H biomarker. The primary endpoint was progression-free survival (PFS), assessed using Response Evaluation Criteria in Solid Tumors (RECIST). ...
Astellas Pharma Inc. announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBL...