Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
Prometheus Biosciences’ comprehensive data set enables target discovery and precision medicine approach in inflammation and immunology
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly
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