FDA Grants Accelerated Approval to Lynozyfic

For 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.

More novel drug approvals.

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.

More approved novel drugs

FDA Lynozyfic Approval Notice