2seventy bio's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by 2seventy bio (TSVT).
Over the past two years, 2seventy bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Abecma. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Abecma (idecabtagene vicleucel) FDA Regulatory Events
Abecma (idecabtagene vicleucel) is a drug developed by 2seventy bio for the following indication: Relapsed and Refractory Multiple Myeloma.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Abecma (idecabtagene vicleucel)
- Announced Date:
- September 25, 2024
- Indication:
- Relapsed and Refractory Multiple Myeloma
Announcement
2seventy bio, Inc announced that the Company, in partnership with study sponsor Bristol Myers Squibb (BMS), will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study evaluating Abecma® (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant.
AI Summary
2seventy bio, Inc. and Bristol Myers Squibb (BMS) have announced that they will stop enrolling new patients in the Phase 3 KarMMa-9 study. This trial was evaluating Abecma® (idecabtagene vicleucel) combined with lenalidomide maintenance versus lenalidomide maintenance alone. The study was focused on patients with newly diagnosed multiple myeloma (NDMM) who did not have a strong response to autologous stem cell transplant.
The decision comes amid improvements in the NDMM treatment landscape, which have resulted in fewer eligible patients than initially expected. By discontinuing enrollment, the companies expect to save over $80 million in near-term costs and move closer to breakeven by 2025. Both partners remain committed to the value and potential of Abecma in addressing the needs of multiple myeloma patients.
Read Announcement- Drug:
- Abecma (idecabtagene vicleucel)
- Announced Date:
- April 5, 2024
- Indication:
- Relapsed and Refractory Multiple Myeloma
Announcement
Bristol Myers Squibb and 2seventy bio, Inc announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial.
AI Summary
On April 4, 2024, Bristol Myers Squibb and 2seventy bio announced that the U.S. Food and Drug Administration approved Abecma® (idecabtagene vicleucel; ide-cel) for adult patients with relapsed or refractory multiple myeloma. This new approval is for patients who have already received two or more treatment lines, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The decision was based on the results from the Phase 3 KarMMa-3 trial, which showed that Abecma tripled progression-free survival and reduced the risk of disease progression or death by 51% compared to standard therapies. Administered as a one-time infusion, Abecma offers patients extended, treatment-free intervals while maintaining a well-established safety profile. This milestone expands treatment options for multiple myeloma patients and underlines both companies’ commitment to advancing cell therapy and increasing global manufacturing capacity.
Read Announcement
2seventy bio FDA Events - Frequently Asked Questions
Yes, 2seventy bio (TSVT) has received FDA approval for Abecma (idecabtagene vicleucel). This page tracks recent and historical FDA regulatory events related to 2seventy bio's drug portfolio.
In the past two years, 2seventy bio (TSVT) has reported FDA regulatory activity for Abecma (idecabtagene vicleucel).
The most recent FDA-related event for 2seventy bio occurred on September 25, 2024, involving Abecma (idecabtagene vicleucel). The update was categorized as "Provided Update," with the company reporting: "2seventy bio, Inc announced that the Company, in partnership with study sponsor Bristol Myers Squibb (BMS), will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study evaluating Abecma® (idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous stem cell transplant."
Currently, 2seventy bio has one therapy (Abecma (idecabtagene vicleucel)) targeting the following condition: Relapsed and Refractory Multiple Myeloma.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TSVT) was last updated on 7/31/2025 by MarketBeat.com Staff
