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FDA approves new uses for BMS’ Opdivo/Yervoy cancer combo

pharmafile | January 25, 2016 | News story | Sales and Marketing BMS, Bristol-Myers Squibb, Yervoy, ipilimumabm melanoma, nivolumab, opdivo, skin cancer 

The FDA has granted Bristol Myers Squibb an expanded indication for its two-cancer drug regimen Opdivo and Yervoy, to treat patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.

This approval expands the original indication for the Opdivo (nivolumab) and Yervoy (ipilimumab) regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status.

The additional indication was approved under the FDA’s accelerated approval pathway, based on progression-free survival (PFS) data from the Phase III CheckMate -067 trial. In this study the combination regimen demonstrated significantly superior progression-free survival versus Yervoy alone. However, continued approval for this indication may depend on the company being able to prove this benefit in confirmatory trials.

The FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients.

Chris Boerner, head of US Commercial, Bristol-Myers Squibb, says: “For nearly a decade, our researchers have worked tirelessly to find treatment options that could improve outcomes for patients with late-stage melanoma, a particularly aggressive cancer, and we are incredibly proud of today’s approval to expand the use of the Opdivo and Yervoy Regimen to include patients with BRAF mutation-positive unresectable or metastatic melanoma.

“CheckMate -067 is the first Phase III study to observe the efficacy and safety of both Opdivo as a single-agent as well as in combination with Yervoy versus Yervoy alone. To make this treatment option available to more patients is truly a milestone in the fight against this deadly disease.”

Opdivo was approved by the FDA in November 2015, for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma. This is the seventh approval for Opdivo in just over a year, and the fourth for late-stage melanoma.

“Patients with metastatic melanoma historically have a very challenging disease. Recent advances in our understanding of the immune response to cancer have yielded therapies which provide meaningful responses and hope.

“The combination of two immuno-oncology treatments, nivolumab and ipilimumab, has been shown to provide these patients with a much needed improvement in progression-free survival and response rates,” says Jedd Wolchok, chief of the melanoma and immunotherapeutics service at the Memorial Sloan Kettering Cancer Centre. “This expanded approval for the nivolumab and ipilimumab regimen provides more advanced melanoma patients with an Immuno-Oncology combination treatment, and the potential for improved outcomes.”

Joel Levy

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