- The FDA approves the use of Bristol-Myers Squibb's (BMY +3.7%) Opdivo (nivolumab) for the treatment of patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
- Opdivo is a PD-1 inhibitor, a protein on cells that blocks the ability of the immune system from attacking and killing cancer cells.
- NSCLC is the most common form of lung cancer, affecting almost 90% of lung cancer patients. There are ~225K new diagnoses of lung cancer in the U.S. each year and ~160K deaths.
- Opdivo was previously approved for the treatment of metastatic melanoma.
- This was an extraordinarily quick approval even under Priority Review. The agency accepted the Biologics License Application (BLA) only six days ago on February 27. The PDUFA date was June 22.
- Previously: FDA accepts Bristol-Myers' Opdivo BLA for lung cancer (Feb. 27)
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