Summary by Moomoo AI
GSK announced that its B7-H3-targeted antibody-drug conjugate (GSK'227) has received FDA Breakthrough Therapy Designation for treating adult patients with relapsed or refractory osteosarcoma who have progressed on at least two prior therapies. This marks the drug's third regulatory designation, following EMA's PRIME designation and FDA's Breakthrough status for small-cell lung cancer in 2024.The designation is supported by data from the ARTEMIS-002 phase II trial, which enrolled over 60 patients, including 42 with osteosarcoma. GSK recently initiated a global phase I trial as part of the development plan to support a registrational pathway for GSK'227, following its acquisition of exclusive worldwide rights from Hansoh Pharma (excluding Greater China).Osteosarcoma, the most common primary bone cancer affecting mainly children and young adults, has an annual incidence of 3.3 patients per million in the US. The condition currently lacks FDA-approved treatments for patients who have progressed on two prior lines of therapy, highlighting a significant unmet medical need in this rare cancer type.
