Bristol Myers Squibb and 2seventy bio, Inc. have announced a development in the treatment of multiple myeloma, as the US Food and Drug Administration (FDA) granted approval for Abecma® (idecabtagene vicleucel; ide-cel). This approval marks a key moment for patients with relapsed or refractory multiple myeloma, offering a new treatment avenue after two or more prior lines of therapy.

The approval is based on data from the KarMMa-3 trial, showcasing Abecma's efficacy in patients who have undergone treatment with an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody. Abecma, administered as a one-time infusion, demonstrates a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma.

Bryan Campbell, Senior Vice President, Head of Commercial, Cell Therapy, at Bristol Myers Squibb, expressed the significance of this approval, stating, "Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey."

Chip Baird, CEO of 2seventy bio, echoed this sentiment, emphasizing the importance of expanding treatment options for patients. "We are extremely pleased that Abecma will be available to many more patients in the US," Baird said. "This approval represents another important milestone for patients, for Abecma, and for 2seventy bio as we remain committed to increasing treatment options and working to improve outcomes for patients living with multiple myeloma."

Despite advancements in treatment, multiple myeloma remains incurable, characterized by periods of remission and relapse. Abecma's approval provides hope for patients who have become triple-class exposed earlier in their treatment journey, offering a clinically meaningful and statistically significant improvement in progression-free survival.

Dr. Al-Ola A. Abdallah, Clinical Associate Professor at the University of Kansas and chair of US Myeloma Innovations Research Collaborative, praised the results of the KarMMa-3 study, emphasizing the potential impact on patient outcomes. "With this approval, these patients now have an opportunity to be treated at an earlier line of therapy with a potentially transformative therapy that offers significantly improved progression-free survival for this difficult-to-treat disease that has had no established treatment approach," Abdallah stated.

To support this approval and future expansions, Bristol Myers Squibb has made investments in increasing manufacturing capacity, ensuring a consistently high manufacturing success rate for Abecma.

This FDA approval follows recent approvals in Japan, Switzerland, and the European Union, solidifying Abecma's position as the only CAR T cell therapy available globally for earlier lines of therapy in patients with triple-class exposed relapsed and/or refractory multiple myeloma.

Additionally, Abecma is approved in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy.