lunedì, 26 luglio 2021
Medinews
8 Gennaio 2018

FDA Grants Adjuvant Dabrafenib/Trametinib Priority Review for BRAF+ Melanoma

December 22, 2017 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of dabrafenib combined with trametinib as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection. The sNDA is based on findings from the phase III COMBI-AD study, in which adjuvant treatment with dabrafenib and trametinib reduced the risk of relapse or death by 53% … (leggi tutto)

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