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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