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Unlocking the Potential of Cell and Gene Therapies

Fierce Pharma, Willis Chandler, Doug Cook and Lung-I Cheng

As the cell and gene therapy market continues to emerge from relative infancy, the innovative products entering the pipeline today offer promise and hope for diseases with high unmet medical needs—from various forms of cancer to central nervous system disorders and cardiovascular diseases. Little known outside the scientific and biomedical realm just a decade ago, the number of cell and gene therapy products in development has surged in recent years, prompting the U.S. Food and Drug Administration (FDA) in 2019 to predict the agency would be approving 10 to 20 CGT products a year by 2025. While experts now believe the number of annual approvals will likely be on the lower end of that projection, there remains significant momentum. In fact, the FDA has approved three new CAR-T products (Abecma, Breyanzi and Carvykti) over the last 16 months, and existing products have expanded their indications to include additional patient populations in earlier lines of treatment.

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