Accelerating market uptake of cell and gene therapies

18 October 2021

By Dr Nicola Davies

One of the latest developments in medicine is the advent of cell and gene therapies (CGTs). Cell therapies include cellular immunotherapies, cancer vaccines, and stem cells. Gene therapies are designed to modify the expression of specific genes or alter the biological properties of cells for the treatment of diseases.

CGT products are regulated by the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER). Currently, there are 22 CGTs approved in the US.1 Among these, recently approved products include Gilead Sciences’ (Nasdaq: GILD) subsidiary Kite Pharma’s brexucabtagene autoleucel (Tecartus), a T cell immunotherapy for mantle cell lymphoma and acute lymphoblastic leukemia,2 and Bristol Myers Squibb (NYSE: BMY) unit Celgene’s idecabtagene vicleucel (Abecma), a cell-based gene therapy for multiple myeloma.3

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