FDA Grants Breakthrough Therapy Designation To GSK's GSK5764227 For Bone Cancer

(RTTNews) - GSK plc (GSK, GSK.L) said that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for GSK5764227, its B7-H3-targeted antibody-drug conjugate (ADC) being evaluated for the treatment of adult patients with relapsed or refractory osteosarcoma (bone cancer) who have progressed on at least two prior lines of therapy.

The Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy.

This is the third regulatory designation for GSK'227, following the European Medicines Agency's decision to grant Priority Medicines (PRIME) designation and the FDA's decision to grant Breakthrough Therapy Designation for relapsed or refractory extensive-stage small-cell lung cancer in August 2024 and December 2024, respectively.

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