FDA Grants Accelerated Approval to Lynozyfic
A bispecific T-cell engager that targets BCMA on myeloma cells and CD3 on T-cellsFor hard-to-treat multiple myeloma
On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (brand name: Lynozyfic) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including:
- A proteasome inhibitor (PI)
- An immunomodulatory agent (IMiD)
- An anti-CD38 monoclonal antibody
How It Works
Lynozyfic is a bispecific T-cell engager that targets BCMA on myeloma cells and CD3 on T-cells, directing the immune system to attack cancer cells.
Clinical Trial Highlights (LINKER-MM1)
- Patients in the study had received a median of 4 prior lines of therapy
- 70% overall response rate (ORR)
- Estimated duration of response (DOR):
- 89% at 9 months
- 72% at 12 months
Safety & Risk
Lynozyfic carries a Boxed Warning for:
- Cytokine Release Syndrome (CRS) — occurred in 46% of patients
- Neurologic toxicity (including ICANS) — occurred in 54% of patients
- Grade 3 or higher neurologic events in 8%
- Grade 3 CRS in <1%
Due to serious risks, the drug is available only through the restricted Lynozyfic Risk Evaluation and Mitigation Strategy (REMS) program. Important components of the REM program include the education of patients, in-hospital dosing, close monitoring and measurement of conditions and results, and a patient wallet card that describes the indicators of CRS and neurologic issues.
Full prescribing information for Lynozyfic will be posted on Drugs@FDA.
Additional warnings
- Infections
- Neutropenia
- Liver toxicity
- Embryo-fetal toxicity
Dosing Overview
- IV administration with step-up dosing: 5 mg → 25 mg → 200 mg
- Then 200 mg weekly ×10, then every 2 weeks
- If stable with partial response or better after week 24: dosing reduced to every 4 weeks
Expedited Designations
- Priority Review
- Fast Track
- Orphan Drug designation
Lynozyfic offers a new immunotherapy option for patients with highly resistant multiple myeloma, though it requires close monitoring due to serious side effects.
Editor’s Note: This is another in our series of potentially game-changing novel pharmaceuticals that FDA approved in 2024 and 2025. This approval report does not in any way recommend or promote this product. For more information contact your oncologist or the manufacturer. Report any adverse effects experienced with this product to FDA’s Medwatch System.
Pimicotinib (Pimjetmi) for Tenosynovial Giant Cell Tumor
On November 10, 2026, the Food and Drug Administration approved pimicotinib (Pimjetmi, EMD Serono, Inc.), a kinase inhibitor, for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or...
Eugia Vancomycin Recall: Glass Particle Contamination
FDA announces voluntary recall of a single lot of vancomycin hydrochloride for injection because of potentially dangerous particulate contamination.Eugia US LLC, formerly Auro Medics Pharma LLC, has initiated a voluntary nationwide recall of one lot of Vancomycin...
FDA Requires New GLP-1 Drug Warning for Vision Loss Risk
Agency cites potential increased risk of rare optic nerve condition following review of clinical trials and postmarket safety dataThe U.S. Food and Drug Administration (FDA) is requiring manufacturers of all glucagon-like peptide-1 receptor agonist (GLP-1 RA)...