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New Cell Therapy Approval Announced

The US Food and Drug Administration (FDA) has granted accelerated approval to Autolus Therapeutics for its therapy, obecabtagene autoleucel (Aucatzyl), for the treatment of relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL).

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Drug Category

Cell Therapy

Drug Name

obecabtagene autoleucel (Aucatzyl)

FDA Approval Date

11/8/2024

Anticipated Cost

$525,000 wholesale list price plus inpatient stay w/ administration cost of at least $261,000

Medical Condition

B-cell precursor Acute Lymphoblastic Leukemia (ALL)

FDA Approval Indication

Adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

US Incidence &
US Prevalence

ALL is one of the most common types of cancer in children, but it is not a common cancer accounting for less than 1% of all cancers. According to the American Cancer Society in 2021: about 5,690 new cases of ALL will be diagnosed in adults and children (3,000 in males and 2,690 in females). There will be about 1,580 deaths from ALL in adults and children (900 in males and 680 in females).

Key Considerations

Inpatient
Adverse reactions
FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia | FDA

ICD-10 Codes

C91.00-C92.92
C95.00-C95.02

J Codes

C9399 and J3590

For full label information and more, visit Package Insert - AUCATZYL

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