Obecabtagene autoleucel, sold under the brand name Aucatzyl, is an anti-cancer medication used for the treatment of acute lymphoblastic leukemia.[1][2] It is a CD19-directed genetically modified autologous T-cell immunotherapy.[1][2]
| Gene therapy | |
|---|---|
| Target gene | CD19 |
| Clinical data | |
| Trade names | Aucatzyl |
| License data | |
| Routes of administration | Intravenous infusion |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
| DrugBank | |
| UNII | |
The most common side effects include cytokine release syndrome, infections-pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, immune effector cell-associated neurotoxicity syndrome, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.[2]
Obecabtagene autoleucel was approved for medical use in the United States in November 2024.[2][3]
Medical uses
editObecabtagene autoleucel is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.[1][2]
Side effects
editThe US Food and Drug Administration (FDA) approved prescribing information for obecabtagene autoleucel has a boxed warning for cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and T-cell malignancies.[2]
The most common side effects include cytokine release syndrome, infections-pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, immune effector cell-associated neurotoxicity syndrome, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.[2]
History
editEfficacy was evaluated in FELIX (NCT04404660), an open-label, multicenter, single-arm trial that enrolled adults with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia.[2] Enrolled participants were required to have relapsed following a remission lasting twelve months or less, relapsed or refractory acute lymphoblastic leukemia following two or more prior lines of systemic therapy, or disease that was relapsed or refractory three or more months after allogeneic stem cell transplantation.[2][4]
The major efficacy outcome measures were rate and duration of complete remission achieved within three months after infusion.[2] Additional outcome measures were rate and duration of overall complete remission which includes complete remission and complete remission with incomplete hematologic recovery, at any time.[2] Of the 65 participants evaluable for efficacy, 27 participants (42%; 95% confidence interval [CI]: 29%, 54%) achieved complete remission within three months.[2] The median duration of complete remission achieved within three months was 14.1 months (95% CI: 6.1, not reached).[2]
The US Food and Drug Administration (FDA) granted the application for obecabtagene autoleucel regenerative medicine advanced therapy (RMAT) and orphan drug designations.
Society and culture
editLegal status
editObecabtagene autoleucel was approved for medical use in the United States in November 2024.[2]
Names
editObecabtagene autoleucel is the international nonproprietary name.[5]
References
edit- ^ a b c d e "AUCATZYL (obecabtagene autoleucel) suspension for intravenous infusion" (PDF). Autolus Limited. U.S. Food and Drug Administration.
- ^ a b c d e f g h i j k l m n o "FDA approves obecabtagene autoleucel for acute lymphoblastic leukemia". U.S. Food and Drug Administration (FDA). 8 November 2024. Retrieved 10 November 2024.
This article incorporates text from this source, which is in the public domain.
- ^ "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)" (Press release). Autolus Therapeutics. 8 November 2024. Retrieved 10 November 2024 – via GlobeNewswire.
- ^ "A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)". ClinicalTrials.gov. Retrieved 12 November 2024.
- ^ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl:10665/340684.
External links
edit- "Obecabtagene autoleucel (Code C172746)". NCI Thesaurus.
- Clinical trial number NCT04404660 for "A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)" at ClinicalTrials.gov
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