First CAR to Pass the Road Test: Tisagenlecleucel's Drive to FDA Approval.

Published in: Clinical cancer research : an official journal of the American Association for Cancer Research (2018)

In August 2017, the FDA took historic action in granting the first approval of gene therapy to tisagenlecleucel. This landmark step brought CAR T-cell therapy to the commercial space and heralded a new era in managing refractory B-cell malignancies and FDA oversight of gene-modified therapies.See related article by O'Leary et al., p. 1142.

Keyphrases

cell therapy
gene therapy
drug administration
stem cells
mesenchymal stem cells
genome wide
copy number
gene expression
bone marrow
genome wide identification