GSK plc (GSK), a pharmaceutical and biotechnology company, on Tuesday announced that the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy Designation for GSK'227, a B7-H3-targeted antibody-drug conjugate or ADC, for the treatment of relapsed or refractory osteosarcoma in adult patients who have progressed after at least two prior lines of therapy.
The FDA's decision is based on promising early data from the ARTEMIS-002 study, a Phase II, open-label, randomized, multi-center trial evaluating the efficacy and safety of GSK'227 in osteosarcoma and other bone and soft tissue sarcomas.
The study has demonstrated significant potential for GSK'227 in this rare and aggressive form of bone cancer, which currently has no FDA-approved treatments for patients with relapsed or refractory disease after two lines of therapy.
Osteosarcoma primarily affects children and young adults and is the most common primary bone cancer, but treatment options are extremely limited once the disease recurs. There is an urgent need for effective therapies in this area.
This marks GSK's third regulatory designation for GSK'227, following Priority Medicines or PRIME designation from the European Medicines Agency and the FDA's Breakthrough Therapy Designation for the same drug in relapsed or refractory small-cell lung cancer.
GSK obtained exclusive worldwide rights to develop and commercialize GSK'227 from Hansoh Pharma, excluding mainland China, Hong Kong, Macau, and Taiwan, in December 2023.
If approved, GSK'227 could become a groundbreaking therapy for patients suffering from osteosarcoma, a cancer with limited treatment options and a high unmet medical need.
GSK closed Monday's (Jan. 04, 2025) trading at $33.96, up 1.46%. In Premarket trading, the stock is up 0.18% at $34.02
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