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
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab
Findings to be featured in a late-breaking proffered paper session at European Society for Medical Oncology (ESMO) Congress 2022
The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.
Acceptance based on results from the phase 3 KEYNOTE-091 trial
This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC
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