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# Novartis Wins Priority Review Voucher for Kymriah Approval
- URL: https://www.fdaweb.com/novartis-wins-priority-review-voucher-for-kymriah-approval/
- Published: 2017-09-08T12:00:00.000Z
- Updated: 2026-09-14T22:48:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139579

FDA has issued Novartis a priority review voucher after approving qualifying rare disease product Kymriah (tisagenlecleucel), indicated for treating certain pediatric and young adult patients with a form of acute lymphoblastic leukemia ([see earlier story](https://www.fdaweb.com/fda-approves-novartis-kymriah-cancer-gene-therapy/)). As amended by the FDA Safety and Innovation Act, the agency awards priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. With the passage of the 21st Century Cures Act, the voucher program has been extended through 9/2020.