Regeneron Secures EU Approval for Bispecific Antibody Lynozyfic, Positioning for Competition Against J&J and Pfizer

EU Approval:
The European Commission granted Regeneron conditional marketing approval for Lynozyfic (linvoseltamab), a bispecific antibody used to treat relapsed/refractory multiple myeloma124.

Indication:
Lynozyfic is indicated for adult patients with multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody24.

Mechanism:
The drug works by bridging B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to trigger T-cell activation2.

Efficacy:
The clinical trial showed a 71% objective response rate, with 50% of patients achieving a complete response or better, and a median duration of response of 29 months5.

Dosing:
The treatment features a response-adapted regimen, allowing administration every four weeks if patients achieve a very good partial response or better after 24 weeks of therapy25.

Competition:
This approval sets up a competitive landscape with J&J and Pfizer in the oncology sector, particularly for multiple myeloma treatments2.

Sources:

1. https://investor.regeneron.com/news-releases/news-release-details/lynozyfictm-linvoseltamab-approved-european-union-treatment

2. https://www.fiercepharma.com/pharma/regeneron-scores-eu-nod-bispecific-antibody-lynozyfic-setting-clash-jj-and-pfizer

4. https://ec.europa.eu/health/documents/community-register/html/h1917.htm

5. https://www.stocktitan.net/news/REGN/lynozyfic-tm-linvoseltamab-approved-in-the-european-union-for-the-slkqk5yqifze.html