News | February 25, 2023
EMA recommends refusal of the marketing authorization for Lagevrio
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
Merck and Ridgeback will appeal the decision and request a re-examination of the CHMP’s opinion.
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US
First PARP inhibitor and new hormonal agent combination approved for these patients in Europe
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial
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
Subscribe To Our Newsletter & Stay Updated
