GSK: obtains 'advanced therapy' status in US

(CercleFinance.com) - GSK announces that the US FDA has granted Breakthrough Therapy status to 'GSK5764227' (GSK'227), an antibody-drug conjugate (ADC) for adult patients with osteosarcoma that has relapsed or is refractory after at least two lines of treatment.


This designation aims to accelerate the development of promising therapies. GSK'227 has already received priority designations from the EMA and FDA for other indications in 2024.

GSK says that this designation illustrates the potential of our targeted ADC for difficult-to-treat cancers. Options for recurrent osteosarcoma are extremely limited, and chemotherapy offers little benefit.

The company notes that its 'GSK'227' is in further clinical trials, including an ongoing global Phase I trial.


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