FDA raises big safety issues in Novartis’ CAR-T review, but spotlights post-marketing path forward
The FDA’s in-house review of Novartis’ groundbreaking CAR-T therapy tisagenlecleucel (CTL019) came out this morning, carefully outlining the efficacy tracked in Phase II and honing in on the agency’s big concern: How do experts in the field view the serious safety issues remain and what would be the best way to track and contain them once marketing begins?
“The overall effectiveness of this product is not the primary issue for consideration by this Committee,” states the review document. But the Phase II study in patients with B-cell acute lymphoblastic leukemia raised a host of issues on short-term and potentially lethal dangers, from a high though familiar rate of cytokine release syndrome to the neurological conditions that CRS can trigger.
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