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The FDA has approved a supplemental Biologics License Application updating the nivolumab dosing schedule to include 480 mg infused every 4 weeks (Q4W) for a majority of approved indications.

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Nivolumab also was approved for a shorter 30-minute infusion across all approved indications.


The Q4W (480 mg) flat dose option is approved for metastatic melanoma (monotherapy or monotherapy phase after combination treatment with ipilimumab); previously treated metastatic non-small cell lung cancer; advanced renal cell carcinoma following prior anti-angiogenic therapy; previously treated locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy; classical Hodgkin lymphoma following relapse/progression after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT; recurrent/metastatic squamous cell carcinoma of the head and neck following platinum-based therapy; hepatocellular carcinoma after prior sorafenib therapy; and adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.