FDA Grants Accelerated Approval to Regeneron's Blood Cancer Drug

Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) received FDA approval for linvoseltamab-gcpt, branded as Lynozyfic, for treating relapsed or refractory multiple myeloma (MM) after at least four prior therapies [1][6][7] - Lynozyfic is a bispecific antibody that connects B-cell maturation antigen (BCMA) on MM cells with CD3-expressing T cells, leading to T-cell activation and cancer cell destruction [2][5] - The approval was based on the LINKER-MM1 trial, which showed a 70% objective response rate and a 45% complete response rate, marking it as one of the most effective bispecific antibodies for this patient group [4][7] Regulatory Approval - Lynozyfic is the first FDA-approved BCMAxCD3 bispecific antibody with a dosing schedule of every two weeks starting at week 14, and every four weeks if a very good partial response is achieved after 24 weeks of therapy [5][7] - The approval addresses a significant unmet need for patients with late-stage MM, who have limited treatment options [6] Market Context - MM is the second most common blood cancer, with over 36,000 new cases expected in the US by 2025 [5] - REGN's shares have declined by 22.9% year-to-date, contrasting with a 0.6% decline in the industry [2] Oncology Portfolio Development - The approval of Lynozyfic enhances REGN's oncology portfolio, which includes Libtayo for various cancers [9] - REGN is also pursuing the approval of odronextamab for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma, with a target action date for resubmission set for July 30, 2025 [10][11] Competitive Landscape - REGN faces challenges with its lead drug Eylea, which is experiencing declining sales due to competition from Roche's Vabysmo, impacting its market share [11][12]