FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
Stivarga is the standard third-line treatment for metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma
This strategic collaboration represents the third clinical trial under Senhwa’s five-year NCI-sponsored cancer research program
3SBio will receive a payment of $1.25 billion. Pfizer will also make a $100 million equity investment in 3SBio
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
3SBio will receive an upfront payment of $1.25 billion and is eligible to receive milestone payments associated with certain development, regulatory and commercial milestones up to $4.8 billion
Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
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