Cancer NetworkOriginal article
<![CDATA[sNDA for Gedatolisib Submitted to FDA in PIK3CA-Mutant Breast Cancer]]>
NDA FilingGedatolisibPositive
AI Analysis
Summary
Gedatolisib manufacturer submitted a supplemental NDA to the FDA to expand the drug's label to HR+/HER2-, PIK3CA-mutant advanced breast cancer based on positive VIKTORIA-1 trial results.
Clinical Trial Data
Primary Endpoint
Met
Outcome Details
sNDA submitted based on positive VIKTORIA-1 trial data
Importance:6/10
Sentiment:
0.70
gedatolisibbreast cancerPIK3CA mutationlabel expansionVIKTORIA-1FDA submission
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Published by Cancer Network on August 27, 2026 3:09 PM