Biopharmaceutical company GSK plc (LSE/NYSE:GSK) announced on Tuesday that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK'227), for the treatment of relapsed or refractory extensive-stage small-cell lung cancer (ES-SCLC).
This designation is based on promising early clinical data demonstrating the potential of GSK'227 to significantly improve outcomes for patients with this aggressive and difficult-to-treat cancer.
GSK acquired global rights to GSK'227 from Hansoh Pharma (HKG:3692) earlier this year. The company plans to initiate global phase 1/2 trials in the second half of 2024 to support a registrational pathway for GSK'227.
Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to offer an improvement over available therapies for serious conditions.
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