Linvoseltamab-Gcpt 5 mg/2.5 mL Suppliers & Bulk Manufacturers
Available Forms: Injection
Available Strengths: 5 mg/2.5 mL
Reference Brands: Lynozyfic (USA/EU)
Category: Oncology Cancer Care
Linvoseltamab‑gcpt is a bispecific T‑cell engager antibody that binds to CD3 on T‑cells and BCMA on malignant plasma (myeloma) cells. This facilitates T‑cell activation and directs T cells to kill multiple myeloma cells. Lynozyfic is indicated for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including a proteasome inhibitor, im‑modulatory agent and an anti‑CD38 antibody).
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Product Description:
Linvoseltamab is a bispecific antibody that links CD3 on a T cell to BCMA on a myeloma cell. BCMA is a near-ideal target: it is expressed on malignant plasma cells and almost nowhere else, which is why it has become the focus of the newest myeloma therapies. Unlike CAR-T approaches directed at the same antigen, this is an off-the-shelf product requiring no cell collection, no manufacturing slot and no bridging therapy while a patient waits.
It is indicated for relapsed or refractory multiple myeloma in adults who have had at least four prior lines including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody — a population with very limited options. It is given intravenously with a step-up schedule to mitigate cytokine release syndrome, which occurs in a majority of patients and is usually confined to the first cycle. Neurotoxicity, serious infection and prolonged hypogammaglobulinaemia requiring immunoglobulin replacement also occur.
Sourcing notes. Originator biologic under patent, recently approved and not yet registered everywhere — confirm status per destination. Cold chain at 2–8 degrees, do not freeze or shake. The receiving centre must be able to monitor inpatients through the step-up doses.
How Linvoseltamab-Gcpt is supplied today, and licensing ahead of patent expiry
Where linvoseltamab is approved
Checked 3 Oct 2026| Market | Status | Brand · regulator · date |
|---|---|---|
| European Union | Approved | Lynozyfic · European Commission · Apr 2025 (conditional) |
| United States | Approved | Lynozyfic · FDA · Jul 2025 |
| Generic / biosimilar | None | None approved as of the check date |
Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →
Frequently Asked Questions
Linvoseltamab‑gcpt is used to treat adults with relapsed or refractory multiple myeloma, particularly those who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody.
It is a bispecific T‑cell engaging antibody produced in cell culture, designed to bind CD3 on T‑cells and B‑cell maturation antigen (BCMA) on multiple myeloma cells, directing T‑cells to kill the cancer cells.
The trade name is Lynozyfic.
It is manufactured by Regeneron Pharmaceuticals, Inc.
The generic name is linvoseltamab‑gcpt.
The brand name is Lynozyfic.
It is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cell culture and formulated as a sterile intravenous drug.
Lynozyfic (Linvoseltamab) is developed and sold by Regeneron. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.
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