Autolus Therapeutics’ Aucatzyl (Obecabtagene Autoleucel) Receives the UA FDA’s Approval to Treat R/R B-Cell Acute Lymphoblastic Leukemia
Shots:
- The US FDA has granted approval to Aucatzyl (B-lymphocyte antigen CD19 CAR T cell therapy) for treating adults with r/r B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)
- Approval was based on the FELIX study for r/r B-ALL, showing overall complete remission (OCR) in 63% (51% with CR & 12% with CRi at any time) in efficacy evaluable patients (n=65), with 42% achieving CR within 3mos. & a median duration of remission of 14.1mos.
- Furthermore, the regulatory submissions of Aucatzyl for r/r ALL were accepted by the EMA & UK’s MHRA in Mar & Aug 2024, respectively, with their review underway
Ref: Autolus Therapeutics | Image: Autolus Therapeutics
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
