Subscribe

Subscribe Today!

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

I'd like to receive:

Kymriah Received Accelerated FDA Approval for Relapsed or Refractory Follicular Lymphoma

JHOP - June 2022 Vol 12, No 3 - FDA Oncology Update, Lymphoma, CAR T-Cell Therapy
Download PDF

On May 27, 2022, the FDA accelerated the approval of a new indication for the CD19-directed CAR T-cell therapy tisagenlecleucel (Kymriah; Novartis) for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. The FDA granted this indication an orphan drug designation.

“The approval of Kymriah offers patients with relapsed or refractory follicular lymphoma a new treatment option and new hope for improving patient outcomes,” Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation, said in a press release. “Having this single infusion treatment option helps to transform the way healthcare providers approach this type of blood cancer.”

The approval was based on the ELARA study, a multicenter, single-arm, open-label clinical trial of adults with relapsed or refractory follicular lymphoma within 6 months after completion of ≥2 lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent) or relapsed after autologous hematopoietic stem-cell transplant.

The main efficacy measures were overall response rate (ORR) and duration of response (DOR). Among the 90 patients in the primary efficacy analysis, the ORR was 86% (95% confidence interval [CI], 77-92), including 68% complete responses. At 9 months, the median DOR was not reached, and 75% of those with a response were still responding to the CAR T-cell therapy. For the 98 patients who underwent leukapheresis, the ORR was 86% (95% CI, 77-92), including 67% complete responses.

The most common (>20%) adverse reactions were cytokine-release syndrome, infection, fatigue, musculoskeletal pain, headache, and diarrhea.

Continued approval for this indication may be contingent on verification of the clinical benefit in confirmatory trial(s).

Related Items
Xalkori Now FDA Approved for the Treatment of ALK-Positive Inflammatory Myofibroblastic Tumor
JHOP - August 2022 Vol 12, No 4 published on August 22, 2022 in FDA Oncology Update
Breyanzi Now FDA Approved for Second-Line Treatment of Large B-Cell Lymphoma
JHOP - August 2022 Vol 12, No 4 published on August 22, 2022 in FDA Oncology Update
Tafinlar plus Mekinist First Tumor Agnostic Therapy Approved for Any Unresectable or Metastatic Solid Tumors with BRAF Mutation
JHOP - August 2022 Vol 12, No 4 published on August 22, 2022 in FDA Oncology Update
FDA Issues New Warning for Copiktra About Increased Risks for Serious Side Effects and Mortality
JHOP - August 2022 Vol 12, No 4 published on August 22, 2022 in FDA Oncology Update
Talquetamab, First-in-Class Bispecific Monoclonal Antibody, Granted Breakthrough Therapy by the FDA for Relapsed or Refractory Multiple Myeloma
JHOP - August 2022 Vol 12, No 4 published on August 22, 2022 in FDA Oncology Update
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, Leukemia
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, Leukemia, Pediatric Cancer
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, Breast Cancer
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, CAR T-Cell Therapy, Lymphoma
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, Prostate Cancer
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.