Drug Approval | May 08, 2024
USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
Positive results reinforce the improved efficacy seen with Opdivo-based treatments in four Phase 3 clinical trials in earlier-stage cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma
The new assets expand Biocon Biologics’ already robust oncology portfolio, which now includes 17 cancer therapies
The FDA aims to make a decision by April 8, 2026
First fully automated, cartridge-based companion diagnostic test for colorectal cancer patients approved in the United States
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab
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
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab
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