Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
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Autolus Therapeutics has received FDA approval for AUCATZYL, a CAR T therapy for adults with relapsed/refractory B-cell acute lymphoblastic leukemia. This approval is significant as it does not require a REMS program, indicating a safer profile. The approval is based on the FELIX clinical trial results.
November 08, 2024 | 9:45 pm
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Autolus Therapeutics has received FDA approval for AUCATZYL, a CAR T therapy for adults with relapsed/refractory B-cell acute lymphoblastic leukemia. This approval is significant as it does not require a REMS program, indicating a safer profile. The approval is based on the FELIX clinical trial results.
The FDA approval of AUCATZYL is a significant milestone for Autolus Therapeutics, as it marks the company's entry into the commercial market with a novel CAR T therapy. The lack of a REMS requirement suggests a favorable safety profile, which could enhance market adoption. This news is likely to positively impact AUTL's stock price in the short term due to the potential for increased revenue and market presence.
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