GSK secures FDA breakthrough therapy designation for GSK5764227 in lung cancer treatment

GSK secures FDA breakthrough therapy designation for GSK5764227 in lung cancer treatment

GSK plc (LSE/NYSE: GSK) has announced a significant milestone in its oncology program, with the US Food and Drug Administration (FDA) granting Breakthrough Therapy Designation for its investigational drug GSK5764227 (GSK’227). This designation, aimed at expediting the development and review of drugs that could offer substantial improvements over existing therapies, underscores the potential of GSK’227 […]

GSK secures expanded approval for Jemperli from FDA: A major advancement in endometrial cancer treatment

GSK secures expanded approval for Jemperli from FDA: A major advancement in endometrial cancer treatment

In a landmark decision, the US Food and Drug Administration (FDA) has extended its approval of Jemperli (dostarlimab) to include all adult patients with primary advanced or recurrent endometrial cancer. This expanded approval now encompasses patients with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumours, which account for the majority of endometrial cancer cases. […]

GSK announces significant survival results for Jemperli in endometrial cancer trial

GSK announces significant survival results for Jemperli in endometrial cancer trial

In a significant development for patients with primary advanced or recurrent endometrial cancer, GSK plc (LSE/NYSE: GSK) has disclosed promising outcomes for Jemperli (dostarlimab-gxly) from the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial. The trial’s Part 1 and Part 2 findings, which showcase notable improvements in overall survival (OS) and progression-free survival (PFS), respectively, were unveiled in a […]