FDA delays decision on BeiGene Tevimbra as a first-line therapy

The U.S. FDA has pushed back the decision date for a first-line label expansion of BeiGene's PD-1 inhibitor, Tevimbra.

In its second quarter financial results and corporate updates, BeiGene shared that the agency had delayed the evaluation of Tevimbra in first-line unresectable, recurrent, locally advanced or metastatic ESCC on account of a delay in scheduling clinical site inspections.

Tevimbra was first approved in March for use in advanced or metastatic esophageal squamous cell carcinoma (ESCC) following prior systemic chemotherapy. The approval was supported by the results of the global phase 3 RATIONALE 302 trial, which demonstrated a significant survival advantage over traditional chemotherapy. 

Initially, BeiGene and Novartis collaborated on developing Tevimbra under a 2021 agreement that permitted Novartis to spearhead regulatory efforts and commercialize the drug globally post-approval. This arrangement has since been amended, now granting BeiGene exclusive global rights to develop, manufacture and market the drug.