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FDA approves new dosing schedule for nivolumab

March 6, 2018—Today, the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application for nivolumab, adding a 4-week dosing option for several of the checkpoint inhibitor’s previous indications.
 
Under the updated license, physicians may now prescribe a 480 mg nivolumab infusion every 4 weeks. This is the first flat dosage option for patients receiving the checkpoint inhibitor. Previously, nivolumab was only available as a 240 mg infusion every 2 weeks. Further, the FDA approved a shorter 30-minute infusion across all indications, cutting infusion time in half.
 
Nivolumab was first approved in December 2014 as a single agent for patients with unresectable or metastatic melanoma who progressed following treatment with ipilimumab and, if BRAFV600-positive, treatment with a BRAF inhibitor. Since then, nivolumab has been granted multiple indications across 8 cancer types.
 
The 4-week schedule of nivolumab is available for the following indications:
 

  • The treatment of patients with metastatic melanoma (as monotherapy or following combination treatment with ipilimumab)
  • The treatment of patients with previously treated metastatic non-small cell lung cancer
  • The treatment of patients with advanced renal cell carcinoma following prior antiangiogenic therapy
  • The treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma with disease progression during or after platinum-based chemotherapy
  • The treatment of patients with classic Hodgkin lymphoma with relapse or progression following stem cell transplantation and brentuximab vedotin, or after 3+ lines of systemic therapy which includes transplantation
  • The treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck following treatment with platinum-based chemotherapy
  • The treatment of hepatocellular carcinoma following treatment with sorafenib
  • The adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection
 
For adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer following progression on previous systemic treatment, this modified dosing schedule is not approved.
 
Updated prescribing information for nivolumab can be found here.
 
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Jonathan A. Bell
Published Online: Tuesday, March 06, 2018


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