BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a leading China-based biotechnology company, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an extension of authorization for its programmed death-1 (PD-1) inhibitor Tevimbra (tislelizumab). The expanded authorization covers gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC).
The CHMP’s positive opinion for G/GEJ adenocarcinoma is for Tevimbra in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative, locally advanced unresectable or metastatic G/GEJ cancer whose tumors express PD-L1 with a tumor area positivity (TAP) score of 5% or more. For ESCC, the recommendation is for Tevimbra in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic ESCC whose tumors also express PD-L1 with a TAP score of 5% or more. These extension applications are based on the results of the RATIONALE-305 and RATIONALE-306 studies, respectively, which demonstrated that the combination of Tevimbra and chemotherapy can improve survival outcomes for patients with GC/GEJC and ESCC compared to placebo combined chemotherapy.
Tevimbra has already been approved in the European Union for the treatment of eligible patients with advanced or metastatic ESCC who have previously received platinum-based chemotherapy, as well as for first-line and second-line treatments of non-small cell lung cancer (NSCLC). The potential expansion of indications further solidifies Tevimbra’s role in the treatment landscape for these cancers.- Flcube.com
