GSK scores regulatory wins for chronic hepatitis B drug, cancer therapy

GSK announced Monday two regulatory milestones: Japan granted its experimental chronic hepatitis B drug first global approval, and the U.S. FDA awarded priority review for a cancer therapy that could be used to treat a type of rectal cancer. GSK said bepirovirsen, branded as Hibsago, was approved in Japan as the first and only “functional cure” for chronic hepatitis B in that country. Late-stage studies showed nearly one in five patients achieved functional cure, and the company expects bepirovirsen to generate more than £2 billion ($2.73 billion) in peak annual sales. Separately, the FDA will conduct a priority review of dostarlimab (Jemperli) for locally advanced rectal cancer, with an FDA action date in February 2027.