The FDA approved nivolumab injection for the adjuvant treatment of patients with melanoma who have involved lymph nodes or metastatic disease and who underwent complete resection.
Regulatory
FDA Grants Adjuvant Dabrafenib/Trametinib Priority Review for BRAF + Melanoma
The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of dabrafenib (Tafinlar) combined with trametinib (Mekinist) as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.
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.
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.