FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma

On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.

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Posted in Melanoma In The News, FDA

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.

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Posted in Melanoma In The News, FDA

FDA Grants Priority Review to Adjuvant Nivolumab in Melanoma

The FDA has granted a priority review to a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor.

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Posted in Melanoma In The News, FDA

FDA accepts application for binimetinib-encorafenib combination for BRAF-mutated melanoma

The FDA accepted for review new drug applications that seek the use of the COMBO450 regimen to treat patients with BRAF-mutant advanced, unresectable or metastatic melanoma, according to the drugs’ manufacturer.

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Posted in Melanoma In The News, FDA

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