sNDA Submitted to FDA for Gedatolisib in PIK3CA-Mutant, HR+/HER2-Negative ...

A supplemental new drug application has been submitted to the FDA seeking approval for gedatolisib in combination with fulvestrant, with or without palbociclib, to treat adult patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer harboring a PIK3CA mutation who have progressed after endocrine therapy. This application aims to broaden the current FDA indication of gedatolisib to include patients regardless of PIK3CA mutation status based on positive phase 3 VIKTORIA-1 trial results.

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