The FDA rejected linvoseltamab, Regeneron’s experimental antibody for multiple myeloma, the company announced Wednesday morning.
In an earnings call earlier this month, Regeneron CEO Leonard Schleifer said there were issues related to “another company’s product candidate” at the third-party manufacturer for linvoseltamab. He said then that a reinspection would be required, and “any potential FDA approval for linvoseltamab is likely to be delayed” beyond the FDA’s deadline of Aug. 22.
Now, Regeneron will have to resubmit to the FDA if it wants approval for linvoseltamab. The company noted that the FDA has not raised issues with linvoseltamab’s safety and efficacy “or the status of our ongoing confirmatory trial.”
This is the second time the FDA has rejected a Regeneron bispecific antibody this year. In March, the agency declined to approve Regeneron’s diffuse large B cell lymphoma bispecific, called odronextamab, over the enrollment status of its confirmatory study.
The third-party manufacturer, which is not named, has since said the issues have been resolved, according to Regeneron, and the facility is awaiting reinspection, which is “expected to take place in the coming months.”
Linvoseltamab is an antibody that binds both cancer cells and T cells, bringing them together so the T cells and immune system can attack the cancer. On myeloma cells, the bispecific antibody binds a target called BCMA, and on T cells it binds CD3.
The FDA has already approved two BCMAxCD3 bispecifics: Johnson & Johnson’s Tecvayli and Pfizer’s Elrexfio.
Regeneron is seeking approval for linvoseltamab in multiple myeloma patients whose cancer has returned or progressed following other treatments. In December, Regeneron reported that 71% of patients responded to treatment at a median of 11 months. However, nearly half of patients experienced cytokine release syndrome — where the immune system overreacts following treatment — and 73% experienced an infection.