The FDA designates Precision BioSciences’ (NASDAQ:DTIL) PBCAR269A, a CAR T cell therapy, for Fast Track review for the treatment of relapsed/refractory multiple myeloma (MM).
The candidate is currently being evaluated in an open-label, parallel assignment, single-dose, dose-escalation and dose-expansion Phase 1/2a clinical trial in MM patients.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
https://seekingalpha.com/news/3612419-precision-bio-car-t-candidate-fast-trackd-for-multiple-myeloma
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