FDA Approvals, News & UpdatesMultiple Myeloma

FDA Approves Abecma, First CAR T-Cell Therapy for Multiple Myeloma

Abecma is the first gene therapy approved by the FDA for patients with multiple myeloma. It uses the patient’s own genetically modified T-cells to fight the cancer.
April 2021 Vol 7 No 2

In March 2021, the FDA approved Abecma (idecabtagene vicleucel; from Bristol Myers Squibb/Bluebird Bio), a BCMA-directed, genetically modified CAR T-cell therapy, for the treatment of adults with multiple myeloma whose disease did not respond to, or returned, after 4 or more lines of therapy. Abecma is the first gene therapy approved by the FDA for the treatment of multiple myeloma.

“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 32,000 of all new cancer cases in the United States.

The FDA approved Abecma based on a study of 127 patients with relapsed or refractory multiple myeloma who had received 3 or more lines of therapy. Approximately 88% of the patients had received 4 or more lines of therapy.

Overall, 72% of patients had a response to Abecma, and 28% of them had a complete response (or remission), most (65%) of which lasted 12 months or more.

The most common side effects of Abecma include cytokine release syndrome, 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.

Share this:

Recommended For You
FDA Approvals, News & UpdatesLeukemiaLymphoma
FDA Approved Rylaze as Part of a Treatment Regimen for Young Patients with Leukemia or Lymphoma
In June 2021, the FDA approved Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn), an asparagine-specific enzyme, to be used as part of a multi-drug chemotherapy regimen for patients older than 1 month with acute lymphoblastic leukemia or lymphoblastic lymphoma who are hypersensitive to asparaginase caused by E. coli infection.
FDA Approvals, News & UpdatesMultiple Myeloma
Darzalex Faspro Receives New FDA Indication, in Combination with Pomalyst and Dexamethasone, for the Treatment of Patients with Multiple Myeloma
In July 2021, the FDA approved a new indication for Darzalex Faspro (daratumumab and hyaluronidase-fihj), for use in combination with Pomalyst (pomalidomide) and dexamethasone, for adults with multiple myeloma who have received at least 1 previous line of therapy.
Last modified: April 28, 2021

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.

Race or Ethnicity
Profession or Role
Primary Interest