What Was Approved?
On July 2, 2025, the FDA granted accelerated approval to Lynozyfic (linvoseltamab-gcpt) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including:
- A proteasome inhibitor
- An immunomodulatory drug
- An anti-CD38 monoclonal antibody
How Does Lynozyfic Work?
Lynozyfic is a BCMA-directed CD3 bispecific T-cell engager.
It is designed to bring T cells into contact with BCMA-expressing myeloma cells so the immune system can attack them.
How Is Lynozyfic Given?
Lynozyfic is given by intravenous infusion using a step-up dosing schedule.
Patients are monitored closely after the initial step-up doses because serious reactions can occur.
Does Lynozyfic Have a Boxed Warning?
Yes.
The FDA label carries boxed warnings for:
- Cytokine release syndrome, or CRS
- Neurologic toxicity, including ICANS
These reactions can be serious or life-threatening.
What Did the Clinical Trial Show?
In the efficacy population of the LINKER-MM1 study, the overall response rate was 70%.
These results come from a single-arm study and do not guarantee the same response for every patient.
Why Was It Granted Accelerated Approval?
Lynozyfic received accelerated approval based on response rate and durability of response.
Continued approval may depend on confirmatory evidence of clinical benefit.
Bottom Line
Lynozyfic (linvoseltamab-gcpt) is an FDA-approved bispecific antibody for adults with heavily pretreated relapsed or refractory multiple myeloma.
Because of risks including CRS and serious neurologic toxicity, treatment requires specialized oncology supervision and close monitoring.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Grants Accelerated Approval to Linvoseltamab-gcpt for Relapsed or Refractory Multiple Myeloma, July 2, 2025.
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Lynozyfic.
- U.S. Food and Drug Administration (FDA) — Lynozyfic Prescribing Information, 2025.