Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum and breast
AstraZeneca says the approval strengthens its push to bring immunotherapy earlier into cancer treatment, where long-term cures are possible
BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results
Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment
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
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
The company has received five final approvals
Data to be presented at the 2022 AACR annual meeting highlights the unique nature of post-chemotherapy derived gene expression signatures in stratifying patient outcomes
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
The medicine is now approved for eight indications across five different types of cancer in China.
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