Regeneron Pharmaceuticals, Inc. — Lynozyfic EMA EPAR public assessment report (EMEA/H/C/006370, 2025)
Regeneron Pharmaceuticals, Inc. · 2025 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Lynozyfic (linvoseltamab) for conditional marketing authorization in relapsed/refractory multiple myeloma (RR MM) for adult patients with at least three prior therapies. Linvoseltamab, a bispecific antibody targeting BCMA, addresses a significant unmet medical need. The report details the drug's mechanism, manufacturing, quality control, and non-clinical pharmacology, highlighting its T-cell mediated cytotoxicity. Clinical data from the Phase 1/2 LINKER-MM1 study (Study 1826) demonstrate high objective response rates and durable responses, particularly with the 200 mg dose. Key safety concerns include cytokine release syndrome (CRS), neurological toxicities (ICANS), and infections. Conditional approval is based on promising efficacy and unmet need, with ongoing Phase 3 Study 2245 expected to confirm the benefit/risk profile and provide long-term data.
Key findings — cited to the page
| median time to first neutropenia grade ≥3 (Q1 CMAXWKE) | 14 weeks | linvoseltamab (REGN5458) · p.50 |
| median time to not getting grade ≥3 infection (Q3 CMAXWKE) | 42 weeks | linvoseltamab (REGN5458) · p.50 |
| OR for grade ≥3 infections (univariate model) | 0.488 | linvoseltamab (REGN5458) · p.50 |
| median time to not getting grade ≥3 infection (Q4 CMAXWKE) | >176 weeks | linvoseltamab (REGN5458) · p.50 |
| median time to not getting grade ≥3 infection (Q1 CMAXWKE) | 15 weeks | linvoseltamab (REGN5458) · p.50 |
| median time to not getting grade ≥3 infection (Q2 CMAXWKE) | 37 weeks | linvoseltamab (REGN5458) · p.50 |
| Chills (All grades) | 10 % | · p.105 |
| Hypophosphataemia (All grades) | 14 % | · p.105 |
| Pyrexia (All grades) | 17 % | · p.105 |
| Fatigue (All grades) | 36 % | · p.105 |
| OR for grade ≥3 infections (multivariate model) | 0.481 | linvoseltamab (REGN5458) · p.50 |
| median time to first neutropenia grade ≥3 (Q2 CMAXWKE) | 17 weeks | linvoseltamab (REGN5458) · p.50 |
Source: Regeneron Pharmaceuticals, Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →