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

Yescarta First CAR T-Cell Therapy Approved for Follicular Lymphoma

JHOP - April 2021 Vol 11, No 2 - FDA Oncology Update, Lymphoma
Download PDF

On March 5, 2021, the FDA approved a new indication for axicabtagene ciloleucel (Yescarta; Kite Pharma), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have received ≥2 lines of systemic therapy. The FDA granted this indication a priority review as well as breakthrough therapy and orphan drug designations.

Axicabtagene ciloleucel was the first CAR T-cell therapy to be approved by the FDA when it was approved for large B-cell lymphoma. The new approval makes it the first CAR T-cell therapy for indolent FL.

“For follicular patients in the third line of therapy, the 5-year survival rate is only 20%, highlighting the urgent need for treatments that offer a real chance for durable remission. Impressively, 91% of follicular lymphoma patients in the ZUMA-5 study responded to a single infusion of axicabtagene ciloleucel, including an estimated 74% of patients in a continued remission at 18 months,” said Caron A. Jacobson, MD, MMSc, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute.

The FDA approval was based on efficacy results from the single-arm, open-label, multicenter ZUMA-5 clinical trial of 146 patients with relapsed or refractory FL who had received ≥2 lines of therapy; 81 of them were evaluable for efficacy. Axicabtagene ciloleucel was administered as a single infusion after lymphodepleting chemotherapy.

The main efficacy measures were overall response rate (ORR) and duration of response (DOR). The ORR in the 81 evaluable patients was 91% (95% confidence interval [CI], 83%-96%), including 60% complete remissions. The median time to response was 1 month, the median DOR was not reached, and the 1-year rate of ongoing remission was 76.2%. In the 146 total study patients, the ORR was 89% (95% CI, 83%-94%), including 62% complete responses.

The most common (≥20%) adverse reactions with axicabtagene ciloleucel in this study were cytokine release syndrome, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, febrile neutropenia, nausea, infection, decreased appetite, chills, diarrhea, tremor, musculoskeletal pain, cough, hypoxia, constipation, vomiting, arrhythmias, and dizziness.

Related Items
Elahere, First FRα-Directed Antibody, FDA Approved for FRα-Positive, Platinum-Resistant Ovarian Cancer
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Rezlidhia New IDH1 Inhibitor FDA Approved for Relapsed or Refractory AML with IDH1 Mutation
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Tecvayli, First Bispecific BCMA-Directed CD3 T-Cell Engager, Received FDA Approval for Relapsed or Refractory Multiple Myeloma
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Imjudo, a New CTLA-4 Inhibitor FDA Approved in Combination with Imfinzi for Unresectable Hepatocellular Carcinoma
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Imjudo FDA Approved with Imfinzi and Chemotherapy for Metastatic Non–Small-Cell Lung Cancer
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Rylaze Received FDA Approval of a New Dosing Regimen
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Adcetris plus Chemotherapy Now FDA Approved for Pediatric Patients with Classical Hodgkin Lymphoma
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Libtayo plus Platinum-Based Chemotherapy Now FDA Approved for NSCLC without Genomic Aberrations
JHOP - December 2022 Vol 12, No 6 published on December 20, 2022 in FDA Oncology Update
Lytgobi FDA Approved for Intrahepatic Cholangiocarcinoma with FGFR2 Fusion
JHOP - October 2022 Vol 12, No 5 published on October 24, 2022 in FDA Oncology Update
Vegzelma a New Biosimilar FDA Approved for the Treatment of 6 Types of Cancer
JHOP - October 2022 Vol 12, No 5 published on October 24, 2022 in FDA Oncology Update
Copyright © The Lynx Group, LLC. All rights reserved.