The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site.

The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution.

Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release.

Regeneron submitted the biologics licence application (BLA) for linvoseltamab under priority review in February this year.

The European Medicines Agency (EMA) is still reviewing the therapy in the same indication, and the application to the EMA was also accepted in February. The agency typically takes up to 210 days to evaluate a marketing authorisation.

An investigational bispecific antibody, linvoseltamab, is aimed at adults with relapsed/refractory multiple myeloma who have undergone treatment with a minimum of three previous therapies.

Regeneron’s candidate works by promoting the interaction of B cell maturation antigen (BCMA) in multiple myeloma cells with CD3-expressing T cells, allowing the immune response cells to exert an effect on cancer cells.

Linvoseltamab was evaluated in the Phase I/II LINKER-MM1 study (NCT03761108), the data from which Regeneron presented at the 2024 EHA Congress in June this year. At a median follow-up of 14.3 months in multiple myeloma patients, a 200mg linvoseltamab dose elicited an objective response rate (ORR) of 71%, with 50% of patients achieving a complete response (CR) or better.

As per estimates, around 35,780 new diagnoses of multiple myeloma will be made in the US in 2024, with around 12,500 deaths expected to occur as a result.

The multiple myeloma market was worth $15.7bn in 2023, according to analysis by GlobalData’s Pharma Intelligence Centre.

The setback marks a tricky mid-year for Regeneron, a company bracing itself for increased competition to its blockbuster ophthalmic drug Eylea (aflibercept). Eylea, jointly developed with Bayer, secured $5.89bn in sales last year, but revenues were down by 6.3% from the year before due to increased competition from Roche’s wet AMD drug Vabysmo (faricimab) and others. Biosimilars to Eylea arrived on the scene in May this year.

Regeneron reported positive sales for the high-dose version of Eylea, however, with US sales notching $304m in Q2 this year. This was up from the $200m Eylea HD generated in Q1, giving a boost to the weakening Eylea franchise.

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