FDA Approves Opdivo Label With Expanded Dosing Options

Drug is first FDA-approved PD-1 inhibitor to offer every-four-week dosing

The FDA has approved a supplemental biologics license application updating the dosing schedule of nivolumab (Opdivo, Bristol-Myers Squibb) to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.

This approval will give health care professionals the flexibility to customize patient care with the option of using the new Q4W (480 mg) flat dose in addition to the previously available option of 240 mg every two weeks (Q2W); a 240-mg vial is now available. 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 Q4W (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, Bristol-Myers Squibb)
  • 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’s lymphoma following relapse/progression after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin (Adcetris, Seattle Genetics) 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 (Nexavar, Bayer Healthcare) therapy
  • Adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.

Nivolumab is associated with the following warnings and precautions, including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; complications of allogeneic HSCT after nivolumab; and embryo-fetal toxicity.

Source: Bristol-Myers Squibb; March 6, 2018.