Obecabtagene autoleucel is a prescription medicine indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It is available as kits. MedsAcross supplies Obecabtagene autoleucel for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
1 INDICATION AND USAGE AUCATZYL is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Source: US FDA prescribing information
AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy consisting of the patient's own T cells expressing an anti-CD19 CAR. Engagement of anti-CD19 CAR-positive T cells with CD19 expressed on target cells, such as cancer cells and normal B cells, leads to activation of the anti-CD19 CAR-positive T cells and downstream signaling through the CD3-zeta domain. Proliferation and persistence by the anti-CD19 CAR-positive T cells following activation are enhanced by the presence of the 4-1BB co-stimulatory domain. This binding to CD19 results in anti-tumor activity and killing of CD19-expressing target cells.
Source: US FDA prescribing information
For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter. Prior to infusion Administer a lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide. Ensure availability of bone marrow assessment results from a sample obtained within 7 days prior to start of lymphodepleting chemotherapy. Premedicate with acetaminophen. Confirm availability of tocilizumab prior to infusion. AUCATZYL Dose and Administration Verify patient's identity prior to infusion. Dosing is based on the Dose Schedule Planner. The total recommended dose of AUCATZYL is 410 × 10 6 CD19 chimeric antigen receptor (CAR)-positive viable T cells. The treatment regimen consists of a split dose infusion to be administered on Day 1 and Day 10 (± 2 days). Dose to be administered is determined by the patient bone marrow blast assessment.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies): Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following AUCATZYL infusion. Monitor complete blood counts. Infections: Monitor patients for signs and symptoms of infection, treat appropriately. Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy. Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome: Administer treatment per institutional standards.
Source: US FDA prescribing information
The most common (non-laboratory) adverse reactions (incidence ≥ 20%) are: CRS, infections - pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage.
Source: US FDA prescribing information
Store AUCATZYL frozen in the vapor phase of liquid nitrogen (below minus 150°C). Do not re-freeze after thawing.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Obecabtagene autoleucel, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Aucatzyl kit Cold chain | Autolus | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Obecabtagene autoleucel and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Obecabtagene autoleucel, including Aucatzyl.
Yes. Obecabtagene autoleucel has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Obecabtagene autoleucel must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Obecabtagene autoleucel is classified under ATC code L01XL (Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XL).
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