Subscribe

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive:

NEW INDICATIONS

Tecartus FDA Approved for Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

JHOP - December 2021 Vol 11, No 6 - FDA Oncology Update
Download PDF

On October 1, 2021, the FDA accelerated the approval of a new indication for brexucabtagene autoleucel (Tecartus; Kite Pharma), a CD19-directed CAR T-cell therapy, for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The FDA granted brexucabtagene autoleucel breakthrough therapy and orphan drug designations for this indication. In 2020, brexucabtagene autoleucel became the first CAR T-cell therapy to receive FDA approval for mantle-cell lymphoma.

This approval was based on the ZUMA-3 study, a single-arm multicenter clinical trial of adults with relapsed or refractory B-cell precursor ALL. Patients received a single infusion of brexucabtagene autoleucel after completion of lymphodepleting chemotherapy.

The efficacy measures were complete response (CR) within 3 months after receiving the CAR T-cell infusion, and the duration of the CR. Of the 54 patients evaluable for efficacy, 28 (52%; 95% confidence interval, 38-66) achieved CR within 3 months. At a median follow-up of 7.1 months, the median duration of CR was not reached, and the duration of CR was estimated to be >12 months for >50% of the patients.

The most common (≥20%) nonlaboratory side effects included fever, cytokine-release syndrome, hypotension, encephalopathy, tachycardias, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.

Related Items
Kymriah Received Accelerated FDA Approval for Relapsed or Refractory Follicular Lymphoma
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update, Lymphoma
Tibsovo Received a New Indication, in Combination with Azacitidine, for Newly Diagnosed Patients with AML and IDH1 Mutation
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update
Vidaza Received New Indication for Patients with Newly Diagnosed Juvenile Myelomonocytic Leukemia
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update
Enhertu Received Regular FDA Approval for Patients with Unresectable or Metastatic Breast Cancer
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update
Yescarta First CAR T-Cell Therapy FDA Approved for Large B-Cell Lymphoma
JHOP - June 2022 Vol 12, No 3 published on June 16, 2022 in FDA Oncology Update
Pluvicto FDA Approved for PSMA-Positive Metastatic Prostate Cancer
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Opdualag, a Novel Immunotherapy Combination, FDA Approved for Advanced Melanoma
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Carvykti Second BCMA-Directed CAR T-Cell Therapy FDA Approved for Multiple Myeloma
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Keytruda Monotherapy FDA Approved for Endometrial Carcinoma with a Biomarker
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Lynparza Receives FDA Approval for Adjuvant Treatment of High-Risk Early Breast Cancer with BRCA Mutation
JHOP - April 2022 Vol 12, No 2 published on May 3, 2022 in FDA Oncology Update
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.