FDA Greenlights Nivolumab as an Adjuvant Melanoma Therapy

Yesterday, nivolumab (Opdivo) was granted regular approval for the treatment of patients with melanoma whose disease spread to the lymph nodes or those with metastatic disease who have undergone resection, according to a press release.

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Posted in Melanoma In The News, FDA

Dabrafenib/Trametinib Granted Priority Review for Stage III BRAF-Mutated Melanoma

The US Food and Drug Administration (FDA) has granted priority review to the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E or V600K mutations after complete disease resection.

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Posted in Melanoma In The News, FDA

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

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Melanoma Google Alerts is a summary of daily articles found in print and on the internet. The articles do not necessarily represent the views of Melbourne Melanoma Project

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