Posted by Michael Wonder on 13 Sep 2021
BeiGene announces U.S. FDA acceptance of biologics license application for tislelizumab in oesophageal squamous cell carcinoma
13 September 2021 - This marks the first ex-China regulatory filing for tislelizumab, following approval in five indications in China.
BeiGene today announced that the U.S. FDA accepted for review a biologics license application for its anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic oesophageal squamous cell carcinoma after prior systemic therapy.
The Prescription Drug User Fee Act target action date is 12 July 2022.
