FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications

  • March 8, 2018

On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications.

This approval will provide health-care professionals the flexibility to customize patient care with the option of using the newly approved every-4-week (480-mg) flat dose in addition to the previously available option of every 2 weeks at 240 mg, now available in a new 240-mg vial. Nivolumab was also approved for a shorter 30-minute infusion across all approved indications. Dosing schedule updates for an additional approved indication for nivolumab may be submitted to the FDA in the future.

The every-4-week (480-mg) flat-dose option is approved for the following indications for nivolumab:

  • Metastatic melanoma (monotherapy or monotherapy phase after combination treatment with ipilimumab [Yervoy])
  • Previously treated metastatic non–small cell lung cancer
  • Advanced renal cell carcinoma following prior antiangiogenic therapy
  • Previously treated locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy
  • Classical Hodgkin lymphoma following relapse or progression after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin (Adcetris), or three or more lines of systemic therapy that includes autologous HSCT
  • Recurrent or metastatic squamous cell carcinoma of the head and neck following platinum-based therapy
  • Hepatocellular carcinoma after prior sorafenib (Nexavar) therapy
  • Adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.

“We continuously learn new ways to individualize treatment with immuno-oncology therapies, and in my experience, what works for one patient may not be optimal for another,”said Jeffrey S. Weber, MD, PhD, Deputy Director of the Perlmutter Cancer Center at NYU Langone Health and Professor of Medicine at NYU School of Medicine, New York. “For instance, some patients may need the support of 2-week visits with their health-care team, while for others, a 4-week interval may be more appropriate and better suited to their treatment needs. With this approval, we now have additional ways to help tailor patient care.”

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