FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CBER Touts Gene Therapy, Vaccine Approvals in FY2018

April 25, 2019
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CBER Director Peter Marks highlighted two gene therapy approvals in a report on the center’s achievements for fiscal 2018.

The two gene therapy approvals were for Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), for treatment of an inherited retinal disease, and Gilead’s Yescarta (axicabtagene ciloleucel), for treatment of certain types of adult, large B-cell lymphoma.

Marks called the year “particularly exciting because of the pace of progress in cellular and gene therapies,” noting that the center received more than 150 INDs for gene therapy products, raising the total count of active INDs to nearly 800 applications.

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