Regeneron Pharmaceuticals’ Lynozyfic (linvoseltamab) has been granted conditional marketing approval by the European Commission (EC) to treat relapsed and refractory (R/R) multiple myeloma (MM).
Patients eligible for the drug will have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and will have also shown disease progression on the last therapy, according to the authorisation.
Over 35,000 new cases of MM, an incurable blood cancer, are diagnosed every year in Europe. Despite current treatments being able to slow disease progression, most patients will ultimately experience relapse and need additional therapies.
Regeneron’s Lynozyfic is a bispecific antibody that works by bridging B-cell maturation antigen on MM cells with CD3-expressing T cells to drive T-cell activation and cancer-cell killing.
The drug can be administered every four weeks if a very good partial response or better is achieved following completion of at least 24 weeks of therapy.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the phase 1/2 LINKER-MM1 trial, which demonstrated a 71% objective response rate at a media follow-up of 14 months, with 50% of patients achieving a complete response (CR) or better and 63% achieving a very good partial response or better.
The minimal residual disease negativity rate in patients achieving a CR or stringent CR was 41%, while the median duration of response was 29 months.
Beyond R/R MM, Regeneron is currently evaluating Lynozyfic across different lines of therapy in the disease, including earlier lines of treatment, as well as plasma cell precursor disorders.
The company’s president and chief scientific officer, George Yancopoulos, said: “We are excited by the potential of Lynozyfic and its differentiated clinical profile, dosing and administration.
“Given the strength of the data, we are pursuing a robust clinical development programme exploring its use – in earlier lines of therapy as monotherapy and in novel combinations – with the hope of further advancing care for patients.”
The US Food and Drug Administration is also currently reviewing the drug in R/R MM, with a target action date of 10 July 2025.