EU regulators have approved BeiGene’s (NASDAQ:BGNE) tislelizumab for the treatment of three types of non-small cell lung cancer, or NSCLC, including as a first and second-line treatment.
The product was approved as a first-line treatment for certain patients with squamous NSCLC in combination with carboplatin and either paclitaxel or nab-paclitaxel.
It was also approved as a first-line treatment in combination with pemetrexed and platinum-containing chemotherapy for certain patients with non-squamous NSCLC whose tumors have PD-L1 mutations, and as a monotherapy for certain patients with NSCLC after prior platinum-based therapy.
The drug was approved for the treatment of lung cancer under the brand name Tizveni. BeiGene plans to combine the lung cancer indications with an approved indication for esophageal cancer under the brand name Tevimbra, with a launched slated for later this year.
Tevimbra is already approved in the US and EU for the treatment of advanced or metastatic esophageal squamous cell carcinoma, or ESCC, after prior chemotherapy. EU and US regulators are also reviewing the drug as a first-line treatment for certain types of esophageal, gastric and gastroesophageal cancers.
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