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Autolus Therapeutics: FDA To Review BLA For Obe-cel

Autolus Therapeutics plc (AUTL) said the FDA has accepted its Biologics License Application or BLA for obecabtagene autoleucel or obe-cel for patients with relapsed/refractory Adult B-Cell Acute Lymphoblastic Leukemia. ....

Robot Corp , Steamist Inc , Us Consumer Product Safety Commission , European Union , State Street , Product Safety Commission , Bokser Home , New Jersey Based Steamist , Autolus Therapeutics , Obe Cel ,

Obecabtagene Autoleucel (obe-cel, AUTO1) for Relapsed/Refractory Adult B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL): Pooled Analysis of the Ongoing FELIX Phase Ib/II Study

Claire Roddie, MD, PhD, presents data from the pooled analysis of the ongoing FELIX phase Ib/II study investigating obecabtagene autoleucel in patients with relapsed/refractory adult B-cell acute lymphoblastic leukemia. ....

San Diego , United States , Obecabtagene Autoleucel , Claire Roddie , Pooled Analysis , Clin Oncol , Median Dor , Felix Study , Obe Cel , Cart Cell Therapy , Car T , Felix Trial , Felix Study Data , Relapsed Refractoryb All , Relapsed Refractoryb Cell Acute Lymphoblastic Leukemia ,

Obe-Cel Elicits High Remission Rates in R/R B-ALL Irrespective of Leukemic Burden

Obecabtagene autoleucel elicited durable responses in patients with relapsed or refractory B-cell acute lymphoblastic leukemia independent of leukemic burden at lymphodepletion, although better outcomes were observed in those with lower burden. ....

United States , United Kingdom , Claire Roddie , American Society Of Clinical Oncology Annual Meeting , University College London , Clinical Oncology Annual Meeting , Obe Cel , Obecabtagene Autoleucel , Cart Cell Therapy , B Cell Acute Lymphoblastic Leukemia , Mlb All , Felix Study , Ash Annual Meeting , Hematologic Malignancies , University College London ,

Obe-Cel Demonstrates Durable, Safe Responses in Relapsed/Refractory B-ALL

Claire Roddie, MD, discusses the rationale for investigating obecabtagene autoleucel in patients with relapsed/refractory B-cell acute lymphoblastic leukemia, details the key topline findings from the FELIX trial, and provides insights on unmet needs that remain for this patient population. ....

Claire Roddie , University College London Hospital , Obe Cel , Car T , Cart Cell Therapy , Mlb All , Felix Trial , Obecabtagene Autoleucel , Acute Lymphoblastic Leukemia , Hematologic Cancer , Cytokine Release Syndrome , Immune Effector Cell Associated Neurotoxicity Syndrome ,

Obe-cel Elicits 76% CR/CRi Rate, 97% MRD-Negativity Rate in Relapsed/Refractory B-ALL

Obecatagene autoleucel was associated with a 76% complete response (CR)/CR with incomplete count recovery rate in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. ....

Obe Cel , Obecatagene Autolucel , Felix Trial , Cart Cell Therapy , Claire Roddie ,