FDA News

FDA grants priority review to Opdivo for resected, high-risk melanoma

The FDA granted priority review to nivolumab for the treatment of patients with melanoma who are at high risk for disease recurrence following complete surgical resection, according to the drug’s manufacturer.

Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, previously received breakthrough therapy designation for this indication.

“Priority review of our supplemental biologics license application and the granting of breakthrough designation are positive steps forward in our goal to address the high unmet need that exists among patients with resected advanced melanoma, many of whom experience disease recurrence,” Murdo Gordon, executive vice president and chief commercial officer at Bristol-Myers Squibb, said in a company-issued release.

The supplemental biologics license application included data from the ongoing randomized, double-blind phase 3 CheckMate-238 study, designed to compare nivolumab with ipilimumab (Yervoy, Bristol-Myers Squibb) in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma.

Researchers randomly assigned 906 patients 1:1 to receive 3 mg/kg nivolumab IV every 2 weeks or 10 mg/kg ipilimumab every 3 weeks for four doses, followed by every 12 weeks starting at week 24 until documented disease progression or unacceptable toxicity.

RFS served as the primary endpoint. Secondary endpoints included OS, RFS by PD-L1 tumor expression, quality of life and safety.

As HemOnc Today previously reported, results showed a significantly higher 18-month RFS rate for nivolumab compared with ipilimumab (66.4% vs. 52.7%; HR = 0.65; 95% CI, 0.51-0.83).

More ipilimumab-treated patients experienced grade 3 or grade 4 adverse events (46% vs. 14%). Ipilimumab-treated patients also were more likely to stop treatment due to any-grade treatment related adverse events (43% vs. 10%), as well as grade 3 or grade 4 treatment-related adverse events (31% vs. 5%).

The FDA granted priority review to nivolumab for the treatment of patients with melanoma who are at high risk for disease recurrence following complete surgical resection, according to the drug’s manufacturer.

Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, previously received breakthrough therapy designation for this indication.

“Priority review of our supplemental biologics license application and the granting of breakthrough designation are positive steps forward in our goal to address the high unmet need that exists among patients with resected advanced melanoma, many of whom experience disease recurrence,” Murdo Gordon, executive vice president and chief commercial officer at Bristol-Myers Squibb, said in a company-issued release.

The supplemental biologics license application included data from the ongoing randomized, double-blind phase 3 CheckMate-238 study, designed to compare nivolumab with ipilimumab (Yervoy, Bristol-Myers Squibb) in patients who have undergone complete resection of stage IIIb/c or stage IV melanoma.

Researchers randomly assigned 906 patients 1:1 to receive 3 mg/kg nivolumab IV every 2 weeks or 10 mg/kg ipilimumab every 3 weeks for four doses, followed by every 12 weeks starting at week 24 until documented disease progression or unacceptable toxicity.

RFS served as the primary endpoint. Secondary endpoints included OS, RFS by PD-L1 tumor expression, quality of life and safety.

As HemOnc Today previously reported, results showed a significantly higher 18-month RFS rate for nivolumab compared with ipilimumab (66.4% vs. 52.7%; HR = 0.65; 95% CI, 0.51-0.83).

More ipilimumab-treated patients experienced grade 3 or grade 4 adverse events (46% vs. 14%). Ipilimumab-treated patients also were more likely to stop treatment due to any-grade treatment related adverse events (43% vs. 10%), as well as grade 3 or grade 4 treatment-related adverse events (31% vs. 5%).

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