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FDA clears new indication for Bristol-Myers Squibb's Opdivo

  • 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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Comments (2)

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BMY has bee driving my attention lately as it seems Opdivo is in the path of becoming a rally god drug, it is building a oncology piplein that must lead to become the company with the highest growth in oncology (see it s recent acquisition for prostate cancer vaccine)

Nevertheless I do not see so much expectation regarding BMY, i am missing something?? why people is not aware of the advances of BMY in oncology???
biochemist profile picture
This is really great news for lung cancer patients. The PD-1 inhibitor class (and other immunotherapies under development) could very well fundamentally change the way that we treat cancer.

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