Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

NEW DRUGS

Abecma First CAR T-Cell Therapy Approved for Multiple Myeloma

JHOP - April 2021 Vol 11, No 2 - FDA Updates, Multiple Myeloma
Download PDF

On March 27, 2021, the FDA approved idecabtagene vicleucel (Abecma; Bristol Myers Squibb/Bluebird Bio), a B-cell maturation antigen (BCMA)-directed, genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adults with multiple myeloma whose disease did not respond to, or recurred, after ≥4 lines of therapy.

Idecabtagene vicleucel is the first BCMA-directed CAR T-cell therapy approved for the treatment of multiple myeloma. The FDA granted this indication orphan drug and breakthrough therapy designations.

“While there is no cure for multiple myeloma, the long-term outlook can vary based on the individual’s age and the stage of the condition at the time of diagnosis. Today’s approval provides a new treatment option for patients who have this uncommon type of cancer,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.

According to the National Cancer Institute, in 2020 multiple myeloma accounted for approximately 1.8% (N = 32,000) of all new cancer cases in the United States.

The FDA approved idecabtagene vicleucel based on results of a multicenter study of 127 patients with relapsed or refractory multiple myeloma after ≥3 lines of therapy. Approximately 88% of the patients had received ≥4 lines of therapy.

Overall, 72% of patients had a response to the study drug, including 28% complete responses. Of the patients with complete responses, 65% had a complete response lasting ≥12 months.

The most common side effects of idecabtagene vicleucel include cytokine release syndrome (CRS), infections, fatigue, musculoskeletal pain, and a weakened immune system. Side effects usually appear within the first 1 or 2 weeks after treatment, but some may occur later.

Severe side effects associated with idecabtagene vicleucel include CRS, hemophagocytic lymphohistiocytosis or macrophage activation syndrome, neurologic adverse events, and prolonged cytopenia, all of which can be fatal or life-threatening. Because of such serious side effects, idecabtagene vicleucel is only available through a REMS program. The FDA is also requiring the manufacturer to conduct a postmarketing observational study to validate the long-term safety of the drug.

Related Items
Tivdak First Antibody–Drug Conjugate FDA Approved for Recurrent or Metastatic Cervical Cancer
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Exkivity Novel Oral Targeted Therapy Approved for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
New CAR T-Cell Therapy Produces Durable Responses in Relapsed or Refractory Multiple Myeloma
Wayne Kuznar
Web Exclusives published on October 11, 2021 in Multiple Myeloma, ASCO Highlights
Pylarify Second Radioactive Imaging Drug FDA Approved for PSMA-Positive Prostate Cancer
Web Exclusives published on October 5, 2021 in FDA Updates
Rylaze FDA Approved as Part of a Treatment Regimen for Pediatric Leukemia and Lymphoma
JHOP - August 2021 Vol 11, No 4 published on August 17, 2021 in FDA Updates
FDA Approved Truseltiq for Metastatic Cholangiocarcinoma with the FGFR2 Biomarker
JHOP - August 2021 Vol 11, No 4 published on August 17, 2021 in FDA Updates
FDA Approves Darzalex Faspro plus Pomalyst and Dexamethasone for Multiple Myeloma
Web Exclusives published on August 10, 2021 in FDA Updates
FDA Approves Avapritinib for Advanced Systemic Mastocytosis
Web Exclusives published on August 10, 2021 in FDA Updates
Pembrolizumab plus Lenvatinib Combination Receives Regular Approval for Advanced Endometrial Carcinoma
Web Exclusives published on August 10, 2021 in FDA Updates
Padcev Receives Regular FDA Approval for Locally Advanced or Metastatic Urothelial Cancer
Web Exclusives published on August 10, 2021 in FDA Updates
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.