Tevimbra gets a different stomach cancer restriction

The second US approval for BeiGene's Tevimbra, as part of a chemo combo in first-line HER2-negative gastric/gastroesophageal junction adenocarcinoma, has come on its December PDUFA date, but shows again the complexity of this space. The FDA has greenlit the drug in patients who express PD-L1 at 1% or higher, following the advice of a September adcom into the first-line stomach cancer approvals of anti-PD-(L)1 drugs; that differs from the EU regulator, which last month imposed a narrower label in this setting, mandating PD-L1 ≥5% expression. The EMA might have been prompted by the supporting Rationale-305 trial, which used 5% expression as the cutoff for a PD-L1 subgroup analysis, suggesting that the FDA's decision was based on the US regulator's own analysis of the trial, using a 1% cutoff. More complexity lies in store for the related setting of front-line oesophageal squamous cell carcinoma, where EU approval for Tevimbra plus chemo came last month – also in ≥5% PD-L1 expressers, despite the supporting study, Rationale-306, using a 10% cutoff. This latter use had a July 2024 PDUFA date, which was missed because of the adcom, and there is still no word on US approval.

Tevimbra approvals: EU vs US

Source: OncologyPipeline.