Shots:
- The EC has approved Aucatzyl (Obecabtagene Autoleucel) for treating pts (≥26yrs.) with r/r B-ALL in all 30 EEA states
- The EC approval was based on the FELIX study (n=100+), which showed that pts in cohort IIA (n=94) receiving ≥1 infusion of obe-cel had a 76.6% CR/CRi rate, with a mDoR of 21.2mos. & mEFS of 11.9mos.; 6 & 12mos. EFS rates were 65.4% & 49.5%, respectively. Data was published in the NEJM.
- Obe-cel is an autologous CD19 CAR T cell therapy with a proprietary CAR, approved by the FDA and authorized by the UK MHRA
Ref: Autolus| Image: Autolus| Press Release
Related News:- Autolus Therapeutics’ Obecabtagene Autoleucel Receives the CHMP’s Positive Opinion for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)
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