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GSK Says Osteosarcoma Drug Candidate Receives FDA Breakthrough Therapy Designation
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GSK Says Osteosarcoma Drug Candidate Receives FDA Breakthrough Therapy Designation
Jan 7, 2025 8:39 AM

11:07 AM EST, 01/07/2025 (MT Newswires) -- GSK (GSK) said Tuesday that its investigational drug GSK5764227 for relapsed or refractory osteosarcoma has received Breakthrough Therapy Designation from the US Food and Drug Administration.

The designation is supported by data from a phase 2 trial conducted by Hansoh Pharma, GSK said, adding it acquired exclusive worldwide rights from Hansoh Pharma last year to advance clinical development and commercialization of the antibody-drug conjugate.

GSK'227 was also granted Priority Medicines designation by the European Medicines Agency and FDA Breakthrough Therapy Designation for relapsed or refractory extensive-stage small-cell lung cancer last year, according to GSK.

GSK shares were up 1% in recent trading.

Price: 34.31, Change: +0.34, Percent Change: +1.02

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