FDA expands Opdivo use for metastatic melanoma

February 3, 2016

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma.

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma.

Earlier this year, FDA approved Opdivo to treat patients with advanced squamous non-small cell lung cancer (NSCLC) and then, in early October, FDA expanded the use of Opdivo to also treat patients with non-squamous NSCLC. In late November, FDA also approved Opdivo for the treatment of patients with metastatic renal cell carcinoma.

Related: Opdivo approved for patients with metastatic renal cell carcinoma

“With this latest approval, both the Opdivo + Yervoy regimen, and Opdivo as a single-agent, are now available and represent important treatment options for patients with advanced melanoma, across BRAF status. For formulary decision-makers, this is particularly important as Opdivo now has seven approvals in just over a year,” said Greg Long, head of U.S. oncology payer marketing, Bristol-Myers Squibb. “With indications in 3 distinct tumor types, supported by extensive phase 3 trials at a consistent dose, Opdivo, as a single-agent and in combination with Yervoy, should be included on all managed care and hospital formularies to ensure it is readily available to patients in need.”

Melanoma is a form of skin cancer characterized by the uncontrolled growth of melanocytes. Metastatic melanoma, Stage IV melanoma, occurs when malignant cells spread through the lymph nodes to distant sites or organs in the body. Early detection is crucial, as melanoma is usually curable when diagnosed and treated in its early stages. However, once the cancer has spread, 5-year and 10-year survival rates in the United States average 15% to 20% and 10% to 15%, respectively.

Related: FDA expands use for lung cancer drug

With the new approval, Opdivo, in combination with Yervoy, is indicated for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. FDA has also expanded approval of Opdivo as a single-agent to include previously untreated BRAF-mutation-positive advanced melanoma patients.

FDA expanded approvals are based on results from a phase 3, double-blind, randomized study that evaluated the Opdivo + Yervoy regimen or Opdivo monotherapy vs. Yervoy monotherapy in patients with previously untreated advanced melanoma. Results from the trial demonstrated a statistically significant improvement in progression-free survival in patients treated with both the Opdivo + Yervoy regimen as well as with Opdivo as a single-agent.

The most common adverse reactions associated with the Opdivo + Yervoy treatment regimen included diarrhea, colitis, and pyrexia. 

Read more: FDA approves additional indication for Opdivo