BeiGene announced that the FDA has postponed action on the BLA for Tislelizumab in 2L ESCC, until required inspections are completed.
The FDA has been unable to conduct mandatory inspections due to COVID-19-related travel restrictions. As a result, the FDA has put BeiGene's application on hold until the inspections are completed.
BeiGene and Novartis will continue to work closely with the FDA to expedite the required inspections. The FDA has yet to announce a new projected action date.
Tislelizumab is being developed globally as a monotherapy and in combination with other medications to treat solid tumor and hematologic cancers. The results of the multi-regional Phase 3 trial, which enrolled 512 patients from Europe, the United States, and Asia, as well as safety data on 1,972 patients, show a significant reduction in the risk of death and a 2.3-month increase in median overall survival.
In January 2021, BeiGene and Novartis announced a partnership in which Novartis will co-develop, manufacture, and market BeiGene's anti-PD1 antibody, tislelizumab, in North America, Europe, and Japan. Aside from that, BeiGene and Novartis signed a licensing agreement for ociperlimab, BeiGene's TIGIT inhibitor currently in Phase 3 development. They recently announced a strategic partnership in which BeiGene will market Novartis Oncology-approved therapies in China.
BeiGene is a leading Chinese novel pharmaceutical company that develops medications that are less expensive but more effective. BeiGene has a research and development and medical team of approximately 2,900 people, and also over 100 ongoing clinical studies.