FDA Fast Track Designation for CLN-049 in R/R AML
“Fast Track designation underscores both the urgent need for new options in relapsed and refractory acute myeloid leukemia and the promise of CLN-049,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “Initial results from our Phase 1 study have shown meaningful efficacy, including complete responses, reinforcing the broad potential of this FLT3-directed T cell engager in a population where effective treatment options are currently limited and fragmented. This regulatory milestone provides important momentum for development, and we look forward to collaborating closely with the FDA to rapidly advance CLN-049 for patients who desperately need more effective therapies.”
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