FDA ushers in a new era in cancer treatment with 'historic' CAR-T approval for Novartis
The FDA has approved the world’s first CAR-T therapy, giving a green light to Novartis for Kymriah (tisagenlecleucel) in what regulators themselves describe as an historic event.
The early approval — about a month ahead of the PDUFA date — came through for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia.
Novartis set the price for the one-time treatment at $475,000, right in line with low-end estimates and one that will put pressure on Gilead to rein in its own price for a rival therapy expected to be approved in the near future.
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