The FDA Has Granted Breakthrough Therapy Designation To GSK's GSK5764227, An Investigational B7-H3-Targeted Antibody-drug Conjugate Being Evaluated For Extensive-stage Small-cell Lung Cancer With Disease Progression On Or After Platinum-based Chemotherapy (Relapsed Or Refractory)
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The FDA has granted Breakthrough Therapy Designation to GSK's investigational drug GSK5764227, which targets B7-H3 for treating extensive-stage small-cell lung cancer that has progressed after platinum-based chemotherapy.
August 20, 2024 | 10:34 am
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GSK's investigational drug GSK5764227 has received FDA Breakthrough Therapy Designation, potentially accelerating its development and approval process for treating relapsed small-cell lung cancer.
The FDA's Breakthrough Therapy Designation is significant as it can expedite the development and review of drugs that show substantial improvement over existing therapies. This designation for GSK5764227 could lead to faster approval and market entry, positively impacting GSK's stock price.
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