Through this article, Jaime Polychrones at Clarivate Analytics
draws attention to the memorable 2017, when the US Food and
Drug Administration (FDA), for the first time in its history, approved
a biologics licence application (BLA) for a gene therapy product.
Kymriah (tisagenlecleucel), a first-in-class CD19-directed genetically
modified autologous T-cell immunotherapy developed by Novartis
Pharmaceuticals Corporation, is indicated for the treatment of patients
up to age 25 years with B-cell precursor acute lymphoblastic leukaemia
that is refractory or in second or later relapse. This approval came on
the heels of a unanimous vote to support licensure of the product
during an FDA Oncologic Drugs Advisory Committee meeting.