Opdivo/ Yervoy Regimen Receives FDA Approval for BRAF V600 Wild-Type Unresectable or Metastatic Melanoma

Opdivo/ Yervoy Regimen Receives FDA Approval for BRAF V600 Wild-Type Unresectable or Metastatic Melanoma

Bristol-Myers Squibb Company announced it has received US Food and Drug Administration (FDA) approval for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) in the treatment of patients diagnosed with BRAF V600 wild-type unresectable or metastatic melanoma – an indication that was previously given accelerated approval.

“Targeting the immune system in the treatment of cancer has been of interest to the oncology community for decades, and our first Immuno-Oncology agent,Yervoy, was approved in 2011 for metastatic melanoma. Opdivo reinforced the power of the immune system in the fight against cancer, and is quickly becoming a foundational component in how the oncology community treats this devastating disease,” said Giovanni Caforio, chief executive officer, Bristol-Myers Squibb. “Today’s approval of the Opdivo Yervoy Regimen marks another first for our research in Immuno-Oncology and represents our unwavering commitment to continually redefine cancer care, and offer patients new treatment options with the goal of improved outcomes.”

Pivotal study CheckMate-069, a Phase 2, double-blind, randomized study that involved 140 participants, served as the basis for the recent FDA approval, successfully demonstrating the regimen’s positive results in previously untreated patients, as measured by improvements in confirmed objective response rate – the primary endpoint. Those treated with the combined regimen exhibited superior improvements compared to those who received monotherapy with either one of the two immuno-oncology agents. Partial responses were noted in 43% of the group who received the combination therapy versus 11% in the Yervoy monotherapy group. Further, the regimen group showed a 60% reduction in cancer progression risk, with an average PFS of 8.9 months.

“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,” said Jedd D. Wolchok, MD, PhD, Chief, Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center. “Today’s approval represents a step forward for the melanoma community, providing hope for patients with metastatic melanoma.”

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