Regeneron's Linvoseltamab Faces FDA Rejection, Not Delay

The FDA recently issued a complete response letter (CRL) to Regeneron Pharmaceuticals concerning their application for linvoseltamab, a treatment for relapsed/refractory multiple myeloma that has worsened after at least three prior treatments. The company hinted at a potential delay for this BCMAxCD3 bispecific antibody earlier this month during its second-quarter financial results.

Regeneron clarified that the FDA's sole concern stemmed from findings during a pre-approval inspection at a third-party fill/finish manufacturer, which was producing a different company's product. Although the issue has been resolved, the third-party facility is awaiting reinspection by the FDA, anticipated to occur in the coming months.

When the potential delay was first noted, Regeneron CEO Leonard Schleifer emphasized that the FDA had not indicated any concerns regarding linvoseltamab's safety, efficacy, or the progress of the ongoing confirmatory trial. He mentioned that the FDA's decision would likely be postponed beyond the initial target date of August 22.

This situation is not isolated. Last year, Regeneron faced a similar CRL for a higher-dose version of Eylea (aflibercept) due to issues found at third-party manufacturer Catalent. Approval was eventually granted shortly after addressing the FDA's concerns. Schleifer pointed out that such manufacturing and inspection issues are becoming an "industry-wide" problem, with the FDA considering a public hearing to address the increasing number of complications related to third-party filler and manufacturing processes in the biopharmaceutical industry.

Additionally, Regeneron noted that the European Medicines Agency is still reviewing a marketing submission for linvoseltamab for the same multiple myeloma indication.