Yervoy (ipilimumab) has received a positive review by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the treatment of unresectable or metastatic melanoma in patients age 12 and older.
Publications
FDA Approves Opdivo For Resected Melanoma
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.
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.