ABECMA
STN: BLA 125736
Proper Name: Idecabtagene Vicleucel
Tradename: ABECMA
Manufacturer: Celgene Corporation, a Bristol-Myers Squibb Company
Indications:
- Treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Product Information
- Package Insert and Medication Guide - ABECMA
- Demographic Subgroup Information – idecabtagene vicleucel [ABECMA]
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- December 1, 2025 Approval Letter - ABECMA
- September 25, 2025 Approval Letter - ABECMA
- June 26, 2025 Approval Letter - ABECMA
- April 4, 2024 Approval Letter - ABECMA
- April 4, 2024 Clinical Review - ABECMA
- April 4, 2024 Statistical Review - ABECMA
- Summary Basis for Regulatory Action - ABECMA
- March 26, 2021 Approval Letter - ABECMA
- Approved Risk Evaluation and Mitigation Strategies (REMS) - ABECMA
- Approval History, Letters, Reviews and Related Documents - ABECMA