Expanded Indication for Opdivo
October 9, 2015 - The U.S. Food and Drug Administration approved an expanded indication for Opdivo (nivolumab – Bristol Myers Squibb). Opdivo is an infused human programmed death receptor -1 (PD-1) inhibitor and the new indication allows Opdivo to be used to treat patients with metastic non-squamous non-small cell lung cancer (NSCLC) that progresses during or after treatment with platinum-based chemotherapy.
Opdivo was originally approved in December 2014 for the treatment of previously-treated patients with unresectable or metastatic melanoma. Then in March, 2015, the FDA approved Opdivo to treat patients with metastatic squamous NSCLC that progresses during or after treatment with platinum-based chemotherapy. Approximately 90% of patients with lung cancer have NSCLC, of which about 70% of the cases are non-squamous.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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