Better late than never for Tevimbra

BeiGene has been waiting since July to get the FDA nod for its PD-1 inhibitor Tevimbra in first-line oesophageal squamous cell carcinoma, and this finally happened on Tuesday. The FDA has taken a similar stance as it did in first-line HER2-negative gastric/gastroesophageal junction adenocarcinoma last December, by greenlighting a chemo combo in patients expressing PD-L1 at 1% or higher. It’s notable that the analogous EU approvals only cover patients with PD-L1 ≥5%. Tevimbra, which now boasts three US indications, originally had a PDUFA date of July 2024 in front-line oesophageal, based on the Rationale-306 study. However, a decision was delayed by a lag in clinical site inspections; an adcom was then scheduled in September to discuss PD-L1 inhibitors in gastric and related cancers, at which point it became apparent that Tevimbra’s approval would likely be limited to PD-L1 expressers. A question is whether this might hold back use, with not all oesophageal patients routinely assessed for PD-L1. Tevimbra sales totalled $621m in 2024, up from $537m in 2023. In the second half of 2025 BeiGene expects EU approval decisions covering first-line SCLC (Rationale-312), (neo)adjuvant NSCLC (Rationale-315) and first-line nasopharyngeal carcinoma (Rationale-309), according to the group’s fourth-quarter earnings presentation.

Tevimbra approvals: EU vs US

Source: OncologyPipeline.