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Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma
Globenewswire· 2025-04-28 11:01
Core Insights - The European Commission has granted conditional marketing approval for Lynozyfic (linvoseltamab) to treat adults with relapsed and refractory multiple myeloma, specifically for those who have undergone at least three prior therapies [1][3][5] - Lynozyfic is a bispecific antibody that targets B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells, facilitating T-cell activation and cancer cell killing [1][3] - The approval is based on the LINKER-MM1 trial, which showed a 71% objective response rate and a 50% complete response rate among patients treated with Lynozyfic [3][4] Company Overview - Regeneron Pharmaceuticals is a leading biotechnology company focused on developing innovative medicines for serious diseases, including blood cancers [17][18] - The company has a strong commitment to transforming cancer care, as evidenced by the approval of Lynozyfic as its second bispecific antibody [5][12] - Regeneron utilizes proprietary technologies, such as VelociSuite, to develop optimized fully human antibodies and bispecific antibodies [15][18] Clinical Development - Lynozyfic is currently being investigated in a broad clinical development program, including monotherapy and combination regimens across different lines of therapy for multiple myeloma [11][12] - The ongoing LINKER-MM1 trial has enrolled over 300 patients, assessing safety, tolerability, and anti-tumor activity [9][10] - The regimen for Lynozyfic includes an initial step-up dosing followed by a response-adapted schedule, allowing for convenient administration every four weeks for eligible patients [2][10] Market Context - Multiple myeloma is the second most common blood cancer, with over 35,000 new cases diagnosed annually in Europe and 187,000 globally [6][7] - Despite treatment advances, multiple myeloma remains incurable, and patients often experience relapses and require new therapies [7][8] - The introduction of Lynozyfic provides a new treatment option with a different mechanism of action, addressing the need for innovative therapies in this patient population [3][5]