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CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals

Data as of June 30, 2021

Application Number Submission Type
and Number
Proprietary Name Established Name Applicant Approval Date Use
BLA 125730 ORIGINAL-1 STRATAGRAFT allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat Stratatech Corporation 15-Jun-2021 Indicated to promote durable wound closure & regenerative healing in the treatment of adult patients with debrided thermal burns that contain intact dermal elements, and for which surgical intervention is clinically indicated.

BLA 125714

ORIGINAL-1

BREYANZI

lisocabtagene maraleucel

Juno Therapeutics, a Celgene Company

05-Feb-2021

Treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.

* RMAT designation was enacted in the 21st Century Cures Act on December 13, 2016.


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