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GSK plc (LSE/NYSE: GSK), a global biopharmaceutical company, announced today that the European Medicines Agency (EMA) has granted its investigational drug, GSK'227, the Priority Medicines (PRIME) designation for the treatment of relapsed extensive-stage small-cell lung cancer (ES-SCLC). This regulatory acknowledgment is based on early clinical data suggesting potential therapeutic benefits in a disease marked by limited treatment options and poor patient outcomes.
The PRIME designation is designed to expedite the development and review of drugs targeting unmet medical needs. GSK'227, an antibody-drug conjugate (ADC) targeting B7-H3, has shown promise in preliminary trials. It is the second major regulatory milestone for GSK'227, following the Breakthrough Therapy Designation it received from the US Food and Drug Administration in August 2024.
Senior Vice President of Global Head Oncology at GSK, Hesham Abdullah, remarked on the significance of this development, noting the potential of GSK'227 to improve treatment for ES-SCLC and other tumor types with limited therapeutic options. The PRIME designation was supported by data from the ARTEMIS-001 study, an ongoing phase I trial conducted by Hansoh Pharma, which assessed the drug's safety and efficacy in over 200 patients with various advanced solid tumors.
Lung cancer remains one of the leading causes of cancer-related deaths globally. In Europe alone, lung cancer accounted for an estimated 484,554 new cases and 375,784 deaths in 2022. ES-SCLC, a particularly aggressive form of lung cancer, often presents with widespread disease at diagnosis and has a high rate of relapse after initial treatment.
Earlier in the year, GSK acquired the rights to further develop and commercialize GSK'227 worldwide, with the exception of mainland China, Hong Kong, Macau, and Taiwan, from Hansoh Pharma. The company's commitment to oncology focuses on leveraging immuno-oncology and tumor-cell targeting therapies to improve survival rates for patients with hematologic malignancies, gynecologic cancers, and other solid tumors.
This news is based on a recent SEC filing by GSK and provides a glimpse into the company's ongoing efforts to advance its oncology pipeline. The information presented here is strictly based on the data provided in the filing and does not include any speculative or forward-looking statements.
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