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Abecma Secures First CAR T Approval for Multiple Myeloma in Japan

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Bristol-Myers Squibb K.K. announced approval for Abecma® (idecabtagene vicleucel) in Japan, marking its expanded use in patients with relapsed or refractory multiple myeloma (RRMM) who’ve undergone at least two prior therapies, including specific agents. This first-in-class BCMA-directed CAR T cell therapy targets BCMA on myeloma cells, enhancing immune response and leading to their elimination.

The approval stems from an interim analysis of the KarMMa-3 Phase 3 study. Patients treated with Abecma showed significantly longer median progression-free survival (mPFS) compared to those on standard regimens. The study also indicated a notable overall response rate (ORR) for Abecma, underscoring its potential as a therapeutic breakthrough. No new safety concerns emerged in patients previously treated with specific agents, affirming Abecma’s tolerability.

Abecma Offers Hope for Ineligible Multiple Myeloma Patients

Dr. Makoto Sugita, Bristol Myers Squibb’s R&D head in Japan, highlighted the critical need for improved therapies in multiple myeloma, particularly for those ineligible for transplant. Abecma’s approval in this setting represents a significant step in addressing these unmet needs, aligning with the company’s dedication to pioneering treatments for severe illnesses.

The positive results from the Phase 3 KarMMa-3 trial will be presented at the American Society of Hematology Annual Meeting, showcasing Abecma’s efficacy in extending progression-free survival. This pivotal trial included patients who had received multiple prior treatments and assessed Abecma against various standard regimens. It demonstrated a statistically significant increase in mPFS and a substantially improved overall response rate compared to traditional therapies.

Multiple Myeloma

KarMMa-3 Study: Abecma Shows Promise as Earlier Treatment Option

The KarMMa-3 study, involving a global cohort, evaluated Abecma’s efficacy against specific standard therapies and showed promising outcomes in terms of PFS, ORR, and safety profile. Further analyses and detailed results will be unveiled during the hematology conference, offering deeper insights into Abecma’s potential as an earlier-line treatment for RRMM.

This approval marks a milestone in expanding treatment options for multiple myeloma patients in Japan, showcasing the potential of Abecma as an effective therapeutic choice earlier in the treatment continuum.

 

Resource: Bristol-Myers Squibb, December 06, 2023

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