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.
Jonathan A. Bell
Published Online: Tuesday, March 06, 2018