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The approval and withdrawal of melphalan flufenamide (melflufen): Implications for the state of the FDA.

In October 2021, melphalan flufenamide (melflufen) was withdrawn from the US market for the treatment of multiple myeloma. The decision occurred based on results from a phase 3 randomized controlled trial (RCT) which showed numerically inferior overall survival, which previously led the FDA to halt...

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Detalles Bibliográficos
Autores principales: Olivier, Timothée, Prasad, Vinay
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Neoplasia Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8866737/
https://www.ncbi.nlm.nih.gov/pubmed/35196605
http://dx.doi.org/10.1016/j.tranon.2022.101374