Gilead Sciences application for breast cancer therapy gets EMA validation
Foster City: Gilead Sciences has recently announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for sacituzumab govitecan-hziy (SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies, including at least one prior therapy for locally advanced or metastatic disease.
The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation.
SG is a first-in-class therapy targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors, such as TNBC, where high expression is associated with poor survival and relapse. Currently, in the European Union (EU), there is no authorized standard treatment regimen with proven benefit in overall survival (OS) for patients with previously treated metastatic TNBC.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.