The combination is approved for advanced endometrial carcinoma that is pMMR or not MSI-H and has progressed after prior systemic therapy
Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs)
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
The companies will work with investigators to share the results with the scientific community
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
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
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
Presentations include new data on investigational medicines – favezelimab (MK-4280), zilovertamab vedotin (MK-2140) and nemtabrutinib – as well as KEYTRUDA (pembrolizumab) in multiple blood cancers
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