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FDA Accepts sBLAs for 4-week Nivolumab Dosing Schedule

Jason Harris
Published: Tuesday, Jul 25, 2017

Elizabeth Plimack, MD

Elizabeth Plimack, MD
The FDA has accepted supplemental Biologics License Applications (sBLAs) seeking to add a second dosing schedule for nivolumab (Opdivo) across all of the PD-1 inhibitor’s monotherapy indications, according to Bristol-Myers Squibb (BMS).

If approved, doctors would be able to prescribe the new dosing schedule of 480 mg of nivolumab every 4 weeks. Nivolumab is currently approved as a single-agent for:
  • Advanced melanoma 240 mg IV infused over 1 hour every 2 weeks
  • Advanced non–small cell lung cancer (NSCLC) 240 mg IV infused over 1 hour every 2 weeks
  • Advanced renal cell carcinoma (RCC) 240 mg IV infused over 1 hour every 2 weeks
  • Metastatic Urothelial carcinoma 240 mg IV infused over 1 hour every 2 weeks
  • Hodgkin lymphoma 3 mg/kg IV infused over 1 hour every 2 weeks
  • Advanced head & neck squamous cell carcinoma 3 mg/kg IV infused over 1 hour every 2 weeks
The FDA is scheduled to issue a final approval decision by March 5, 2018.
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