BMS and 2seventy bio Announce FDA Acceptance of sBLA for Abecma (idecabtagene vicleucel) in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma

On April 17, Bristol-Myers Squibb (BMS) and 2seventy bio jointly announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received immunomodulatory agents, proteasome inhibitors, and anti-CD38 monoclonal antibody therapy. The PDUFA goal date is set for December 16, 2023.

Abecma was approved by the FDA in March 2021 based on the pivotal Phase II KarMMa study data for the treatment of adult patients with relapsed or refractory multiple myeloma who have received four or more prior lines of therapy, becoming the first FDA-approved CAR-T cell immunotherapy targeting B-cell maturation antigen (BCMA).

Phase III KarMMa-3 Study Shows that at a Median Follow-Up of 18.6 Months, Patients Treated with Abecma (n=254) Demonstrated Clinically Meaningful and Statistically Significant Improvement in the Primary Endpoint of Progression-Free Survival (PFS) Compared to the Standard Regimen (n=132), with Median PFS of 13.3 Months (95% CI: 11.8-16.1) vs. 4.4 Months (95% CI: 3.4-5.9) (HR: 0.49; p<0.0001), Indicating That Abecma Reduced the Risk of Disease Progression or Death by 51%.

The results of KarMMa-3 mean that Abecma is the first CAR-T cell therapy to be proven more effective than standard care in patients with triple-class refractory multiple myeloma in a Phase III randomized controlled trial.

In addition, the European Medicines Agency and Japan's Ministry of Health, Labour and Welfare have also accepted the new indication marketing application for Abecma submitted by BMS based on the KarMMa-3 study.

"We continue to advance Abecma into earlier lines of therapy, committed to increasing treatment options and improving outcomes for patients with multiple myeloma," said Anne Kerber, Senior Vice President and Head of Cell Therapy Development at BMS. "The FDA's acceptance marks another step forward in our mission, bringing us closer to providing this potentially transformative, one-time CAR-T treatment option to more patients."

"The positive results of our Phase III KarMMa-3 study demonstrate that Abecma provides significant clinical benefit in patients with triple-class refractory multiple myeloma," said Steve Bernstein, M.D., Chief Medical Officer of 2seventy bio. "The acceptance of the sBLA brings us one step closer to potentially expanding the benefits of Abecma to earlier lines of therapy for patients with multiple myeloma."

Multiple Myeloma is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. It is the second most common hematologic malignancy in many countries and predominantly affects the elderly. Most patients relapse after initial treatment, with the degree and duration of response, as well as survival outcomes, diminishing with each subsequent therapy. Patients with relapsed or refractory multiple myeloma who have been exposed to three major drug classes—immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies—have poor clinical outcomes, with response rates of only 20%-30%, remission lasting just 2-4 months, and very low survival rates.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably quote. When quoting, please clearly indicate the source of the article in a prominent position; if you need to reprint, please leave a message to the WeChat Official Account backend or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and cannot be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content in this article.

Wonderful Live Broadcast

CUBE LIVE

PharmaCube Reader Survey Questionnaire

Thank You for Your Support. We Look Forward to Your Feedback.

Scan the QR code to provide valuable suggestions