According to BeiGene, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion, recommending approval for the expansion of BaiZeAn& reg; Indications for the treatment of gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC) patients. For ESCC patients, CHMP's positive opinion supports Baize An& reg; Combination platinum chemotherapy is used as first-line treatment for HER-2 negative, locally advanced, or metastatic ESCC adult patients with PD-L1 TAP score ≥ 5%.
Florian Lordick, Director of the Cancer Center and Professor of Oncology at Leipzig University in Germany, stated that although there have been some advances in the treatment of advanced gastric/gastroesophageal cancer and esophageal cancer in recent years, the survival rate of these patients is still the lowest among all types of cancer, and patients still need new treatment options. Research has shown that compared to placebo combined chemotherapy, the combination of trastuzumab and chemotherapy can improve patient survival, highlighting the potential of trastuzumab to bring better treatment outcomes to eligible patients.
Mark Lanasa, Senior Vice President and Chief Medical Officer of Solid Tumors at BeiGene, stated that BeiGene&Co; reg; It has a cornerstone significance in BeiGene's solid tumor product line. The company has always been committed to providing assistance to cancer patients in Europe and around the world. Recently, BeiGene has started providing BeiGene An&B services to eligible first - and second-line NSCLC patients, as well as second-line ESCC patients in EU countries; reg;。 Patients with newly diagnosed ESCC and G/GEJ often face the dilemma of poor prognosis and limited treatment options. Based on the positive opinion of CHMP, BeiGene can bring this innovative therapy to eligible patients more quickly.
It is reported that Baize An& reg; 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 treatment of three indications for non-small cell lung cancer (NSCLC).