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FDA Actions & Updates

The latest approvals, designations, and new indications from the U.S. Food and Drug Administration for oncology drugs.

Thursday, October 1, 2015

FDA Approves Opdivo-Yervoy Combo for Melanoma, First Combo Immunotherapy Regimen for Cancer

The U.S. Food and Drug Administration has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Opdivo is a PD-1 checkpoint inhibitor and Yervoy is a CTLA-4 checkpoint inhibitor. This approval is the first approval of a combination regimen of two immuno-oncology agents for the treatment of cancer.

 

“Historically, metastatic melanoma has been a difficult disease to treat. Now, a new treatment option based on the combination of two valued immuno-oncology agents demonstrates significant efficacy versus ipilimumab (Yervoy) in metastatic melanoma,” Jedd D. Wolchok, MD, PhD, Chief of the Melanoma and Immunotherapeutics Service in the Department of Medicine and at the Ludwig Center at Memorial Sloan Kettering Cancer Center, said in a news release. “Today’s approval represents a step forward for the melanoma community, providing hope for patients with metastatic melanoma.”

 

The Opdivo-Yervoy combination is being approved under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.

 

Safety and Efficacy

Safety and efficacy for the Opdivo-Yervoy combination were established in the Phase II, double-blind CheckMate-069 trial of 142 patients with previously untreated unresectable or metastatic melanoma who were randomized to receive Opdivo with Yervoy or Yervoy alone (OT 6/10/15 issue). Median progression free survival for the patients with BRAF wild-type melanoma was 8.9 months for patients receiving the combination compared with 4.7 months for patients receiving Yervoy alone.

 

Serious adverse reactions were more common in the patients receiving the combination regimen than for patients receiving Yervoy alone. The most common serious adverse reactions associated with the combination regimen were colitis, diarrhea, pyrexia, and pneumonitis. Other common adverse reactions for patients receiving the combination therapy were: rash, pruritus, headache, vomiting, and colitis.

 

Responses from the Oncology Community

The approval was applauded by the Melanoma Research Foundation in a statement from Tim Turnham, the organization’s Executive Director: “Today’s approval marks a turning point in melanoma treatment.  For the first time patients will have access to a regimen that utilizes two critical findings—that the patient’s own immune system can be engaged in the fight against cancer, and that the right combination of two or more drugs can have a synergistic effect.”

 

And the decision was also praised by the Society for Immunotherapy of Cancer. In a statement, SITC President Howard L. Kaufman, MD, FACS, of Rutgers Cancer Institute of New Jersey, said: “Today marks a milestone in the field of cancer immunotherapy. … Not only does this combination immunotherapy demonstrate an impressive, durable response in patients with metastatic melanoma, but today’s approval also illustrates the potential advantage of combining immunotherapy agents offering previously unavailable options to cancer patients.”

 

Both drugs are marketed by Bristol-Myers Squibb.