BioTuesdays

Precision BioSciences gets FDA fast track designation for second allogeneic CAR-T cell therapy

Precision BioSciences’ (NASDAQ:DTIL) allogeneic chimeric antigen receptor (CAR-T) cell therapy, PBCAR269A, received FDA fast track designation for the treatment of relapsed/refractory multiple myeloma. 

PBCAR269A previously received FDA orphan drug designation for the same indication. 

“Fast track designation will help us expedite our allogeneic CAR-T cell therapy program aimed to address the unmet medical need among patients with relapsed/refractory multiple myeloma,” Dr. Chris Heery, Precision BioSciences’ CMO, said in a statement.

“We look forward to working more closely with the FDA as we continue to investigate PBCAR269A as a potential new treatment option that can be more broadly available to patients who otherwise may be ineligible or unable to access existing autologous CAR-T therapies,” he added.

This is the company’s second CAR-T therapy to receive both FDA fast track and orphan drug designations. Precision’s first CAR-T therapy, PBCAR0191, received FDA fast track designation for the treatment of advanced B-cell precursor acute lymphoblastic leukemia and orphan drug designation for the treatment of mantle cell lymphoma.

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