BeiGene wins first US approval for anti-PD-1, with label expansions in the queue
14 Mar 2024
Phase 3Drug ApprovalLicense out/inClinical Result
The FDA approved BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) as a second-line esophageal cancer treatment Thursday, marking its first US clearance after a series of setbacks.
Tevimbra will be available next half to treat adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) who have received prior systemic chemotherapy that did not include a PD-(L)1 inhibitorPD-(L)1 inhibitor.
The approval was based on data from the Phase III RATIONALE 302 study, which enrolled 512 patients from Europe, the US and Asia. Data showed that the anti-PD-1 monoclonal antibody (mAb) demonstrated a 30% reduction in the risk of death and extended median overall survival by 2.3 months compared to chemotherapy.
Path to approval
Tevimbra’s FDA approval comes more than a year and a half later than originally expected.
The agency’s review, originally slated for July 2022, was deferred after it was unable to conduct required inspections in China due to COVID-19 related travel restrictions.
And last September, BeiGene regained global rights to Tevimbra after partner Novartis ended a licensing deal. The Swiss drugmaker had paid $650 million upfront in 2021 for rights to the mAb in several major markets outside China. However, the deal termination came the same day European regulators approved the drug to treat ESCC.
The FDA is also reviewing applications to expand Tevimbra’s label to include a first-line indication for ESCC, as well as to treat locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The agency is expected to make a decision on each indication by July and December 2024, respectively.
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