Regeneron gets a European reprieve

Regeneron’s odronextamab was knocked back by the FDA earlier this year, but European regulators apparently have no qualms about the project. On Friday the EU’s CHMP recommended conditional approval of the CD20 x CD3 bispecific for third-line or later follicular lymphoma and diffuse large B-cell lymphoma. The proposed brand name is Ordspono.

According to Regeneron, the FDA rejection was solely due to odronextamab’s confirmatory trials still being in their dose-finding stages. However, the fact that the group is still looking for a dose window highlights a problem that has been apparent for some time: odronextamab looks efficacious, but has been linked with a high rate of infection-related deaths, according to the phase 2 Elm-2 trial on which the US and EU filings were based.

For its part, the company has said that dose finding is particularly relevant where odronextamab is being used as part of a combo, and three of the group’s five Olympia pivotal trials are testing the agent alongside other drugs. Three of these studies, Olympia-1, 2 and 5, could serve as the confirmatory trial in follicular lymphoma, while Olympia-3 is the confirmatory trial in DLBCL.

In the US Regeneron could have another issue: Roche’s rival CD20 x CD3 bispecific Columvi could soon be heading for full approval based on strong data from the Starglo study. If Columvi gets the full nod this could call into question the availability of an accelerated pathway for odronextamab by the time Regeneron resubmits.

Regeneron has another big test coming soon: its BCMA x CD3 project linvoseltamab, which has also been linked to infection-related deaths, is due an FDA decision by 22 August, and a ruling by the CHMP is expected a few months later. That project’s confirmatory trial, Linker-MM3, is currently recruiting and doesn’t have a dose-finding portion, Regeneron has noted.

While there are still plenty of questions about odronextamab in the US, at least the project should soon join Columvi and AbbVie/Genmab’s Tepkinly on the European market. Both the rival products have conditional EU approvals for relapsed/refractory DLBCL, but not for the slower-growing follicular lymphoma; however, Tepkinly also got a positive opinion on Friday for third-line or later FL.