Just minutes after announcing it had gained back the global rights to its PD-1 inhibitor from Novartis, BeiGene shared that the European Commission approved the drug.
The drug, branded Tevimbra, was approved in the EU as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. Additionally, the U.S. FDA accepted the drug's BLA for use as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
BeiGene and Novartis were co-developing the drug under an agreement signed in 2021 which gave Novartis responsibility for regulatory submissions and granted the drugmaker rights to commercialize in most of the world following regulatory approval. Now, according to BeiGene, the partners have reached a deal that returns the worldwide rights to develop, manufacture and commercialize Tevimbra to BeiGene.
According to BeiGene, in trials, Tevimbra has delivered clinically meaningful improvements in survival benefits and quality of life for cancer patients across a range of tumor types — in many cases, regardless of PD-L1 status — both as a monotherapy and in combination with other regimens. Novartis, will continue to explore Tevimbra's potential in combination with the company's oncology assets.
