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FDAnews Drug Daily Bulletin

Novartis Wins Priority Review Voucher for Kymriah

Sept. 13, 2017

The FDA awarded a priority review voucher to Novartis in conjunction with the company’s approved rare pediatric disease application for Kymriah (tisagenlecleucel), the history-making CAR-T treatment by genetic modification of a patient’s immune cells to fight cancer — specifically, B-cell precursor acute lymphoblastic leukemia in relapsed patients.

The voucher entitles the sponsor who holds it to priority review of a subsequent application for approval of a new drug — one whose active ingredient has not been approved for another product.

The priority review is designed to occur in six months instead of the usual 10. The voucher may be transferred or sold to a different sponsor.

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