FDA Approves New Myeloma Drug | Regeneron vs J&J & Pfizer

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Regeneron’s Lynozyfic Secures Fda Approval For Multiple Myeloma Treatment

New York, July 3, 2025 – Regeneron Pharmaceuticals has significantly expanded its oncology portfolio.The Fda granted accelerated approval to Lynozyfic (linvoseltamab-gcpt), a novel bispecific antibody developed for the treatment of multiple myeloma. Multiple myeloma is the second most prevalent form of blood cancer, marking a crucial advancement in patient care.

breakthrough In Multiple Myeloma Therapy

Relapse is a common challenge in treating multiple myeloma, a cancer affecting plasma cells. Patients often require different treatment approaches as the disease progresses.Lynozyfic is now approved for adult patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy. Regeneron’s Lynozyfic offers a new avenue for these patients.

Lynozyfic leverages Regeneron’s VelocImmune technology to produce fully human antibodies. This bispecific antibody is designed to simultaneously target BCMA on multiple myeloma cells and CD3 on T cells,activating the T cells to eliminate cancer cells.

Clinical Trial Success And Dosing Advantages

The Fda’s approval was based on Phase 1/2 clinical trial data. The data included a group of 80 patients who had received at least four prior lines of therapy. These patients showed a 70% objective response rate. At a median follow-up of 11.3 months, the estimated duration of response was 89% at nine months and 72% at 12 months.

Lynozyfic is administered intravenously every two weeks following initial step-up dosing. Dosing can be extended to every four weeks for patients showing a very good or partial response. This offers a more convenient dosing schedule compared to some other bispecific antibodies used in multiple myeloma treatment.

Did You Know? Bispecific antibodies like Lynozyfic represent a cutting-edge approach to cancer immunotherapy by engaging the patient’s own immune cells to fight cancer.

Comparison with Existing Therapies

Several other bispecific antibodies are available for multiple myeloma. Johnson & Johnson’s Tecvayli (teclistamab-cqyv) initially required weekly management but now offers biweekly dosing. J&J also markets Talvey (talquetamab-tgvs), which has a weekly or biweekly dosing schedule. Pfizer’s elrexfio (elranatamab-bcpf) is administered every two weeks. Lynozyfic’s response-adapted dosing provides a unique advantage.

Drug Name	Target	Dosing Schedule
Lynozyfic (linvoseltamab-gcpt)	BCMA/CD3	Every 2-4 weeks
Tecvayli (teclistamab-cqyv)	BCMA/CD3	Every 1-2 weeks
Talvey (talquetamab-tgvs)	GPRC5D/CD3	Every 1-2 weeks
Elrexfio (elranatamab-bcpf)	BCMA/CD38	Every 2 weeks

Expert commentary

Dr. Sundar Jagannath, Network Director of the Center of Excellence for Multiple myeloma at Mount Sinai, emphasized the importance of Lynozyfic. He noted its potential to reduce treatment burden due to its response-adapted dosing regimen.

Pro Tip: Response-adapted dosing allows for a more personalized treatment approach, possibly improving patient outcomes and quality of life.

global Availability And Regulatory Considerations

Lynozyfic is already available in Europe, having been approved in April. The European Commission’s approval requires Regeneron to provide additional clinical data. The Fda’s accelerated approval also mandates a Phase 3 confirmatory study. An earlier submission to the Fda was turned down due to manufacturing issues at a third-party facility.

Safety Profile

the Lynozyfic label includes a black box warning for cytokine release syndrome and neurotoxicity. Similar warnings are present on other cancer immunotherapy labels. The Fda requires a Risk evaluation and Mitigation Strategy (REMS) to manage these risks.

Regeneron’s Broader Oncology Strategy

Regeneron’s oncology pipeline is anchored by Libtayo, a checkpoint inhibitor with $1.2 billion in global sales in 2024. Odronextamab, another bispecific antibody, is under Fda review for relapsed or refractory follicular lymphoma, with a decision expected by July 30.

Understanding Multiple myeloma: An Evergreen Guide

Multiple myeloma is a cancer that forms in plasma cells, a type of white blood cell responsible for producing antibodies. These malignant plasma cells accumulate in the bone marrow and crowd out healthy blood cells. While there’s no cure, treatments aim to manage the disease and improve quality of life.

Risk Factors and Symptoms

Risk factors include older age, male gender, African-American ethnicity, and a family history of the disease. Symptoms can include bone pain, fatigue, frequent infections, and kidney problems. Early diagnosis and treatment are crucial for managing the condition effectively.

Emerging Therapies

Beyond bispecific antibodies like Lynozyfic, other emerging therapies include CAR-T cell therapy and novel small molecules. These advancements offer hope for improved outcomes and prolonged survival for patients with multiple myeloma.

Frequently Asked Questions About Multiple Myeloma and Lynozyfic

What is multiple myeloma?

Multiple myeloma is a cancer of plasma cells that affects the bone marrow and can lead to various health complications.

How does Lynozyfic treat multiple myeloma?

Lynozyfic is a bispecific antibody that targets both cancer cells and T cells, activating the immune system to kill the myeloma cells.

What are the side effects of Lynozyfic?

Common side effects include cytokine release syndrome and neurotoxicity, which are managed through a Risk Evaluation and Mitigation Strategy (REMS).

How often is Lynozyfic administered?

Lynozyfic is given as an intravenous infusion every two weeks, with the potential to extend to every four weeks based on patient response.

What is the objective response rate with lynozyfic?

Clinical trials showed an objective response rate of 70% in patients who had received at least four prior lines of therapy for multiple myeloma.

Is Lynozyfic available in Europe?

Yes,Lynozyfic has been approved in Europe for the treatment of relapsed or refractory multiple myeloma.

What other treatments are available for multiple myeloma?

Other treatments include Tecvayli, Talvey, elrexfio, CAR-T cell therapy, and various chemotherapy regimens for multiple myeloma patients.

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