FDA Approves New Opdivo Dosing for Metastatic Melanoma, Squamous Cell Carcinoma

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to include a new dosing schedule for Opdivo (nivolumab) as a 480 mg infusion given 4 weeks for a majority of its indications. 

This update now provides patients with 2 dosing options: 480 mg every 4 weeks as a flat dose or 240 mg every 2 weeks, now available in a new 240 mg vial.

In addition, the FDA also approved Opdivo for a shorter 30-minute infusion for all approved indications. 

The new 480 mg every 4 weeks dosing option is approved for the following Opdivo indications:

• Metastatic melanoma (monotherapy or monotherapy phase after combination treatment with Yervoy [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 3 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
• Adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease

Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is available as a 10 mg/mL strength for intravenous (IV) injection in 4 mL, 10 mL, and 24 mL single-use vials. 

Reference

Bristol-Myers Squibb’s Opdivo® (nivolumab) now the first and only FDA-approved PD-1 inhibitor to offer every four-week dosing [press release]. Princeton, NJ: Bristol-Myers Squibb; March 6, 2018. Accessed March 7, 2018.

This article originally appeared on MPR