FDA Approves Tecartus for Relapsed or Refractory B-Cell Precursor ALL

On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Clinical Evidence: ZUMA-3 Trial

The approval was supported by the ZUMA-3 (NCT02614066) trial, a multicenter, single-arm study. Adult patients with relapsed or refractory B-cell precursor ALL received a single infusion of Tecartus following lymphodepleting chemotherapy.

Efficacy Results

The primary efficacy endpoint was the rate of complete remission (CR) within three months of infusion and the duration of that remission.

• Analysis Set: 54 evaluable patients.
• Complete Remission Rate: 52% (28 patients) achieved CR within three months.
• Duration of Response: With a median follow-up of 7.1 months, the median DOR was not reached; however, approximately half of the responders were estimated to maintain CR for over 12 months.

Safety and Side Effects

Tecartus carries a boxed warning for Cytokine Release Syndrome (CRS) and neurological toxicities.

• CRS Incidence: 92%
• Neurological Toxicity Incidence: 87%

Common Adverse Reactions (incidence ≥ 20%): Fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection, constipation, decreased appetite, and vomiting.

Dosage and Administration

The recommended dose is a single intravenous infusion of 1 x 10⁶ CAR-positive T cells per kg of body weight (up to a maximum of 1 x 10⁸ cells), administered after lymphodepleting chemotherapy.

Source: FDA - Tecartus Approval for Adult ALL

#Leukemia #ALL #CAR_T #Tecartus #Immunotherapy #FDAApproval

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