At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab
Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers
First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm
The studies demonstrate a standardized strategy to extend mechanistic modeling and systems pharmacology into drug safety and mode of action assessments that has relevance for drug development and a variety of other contexts
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