Shots:
- The US FDA has received an NDA of gedatolisib under the RTOR program for the treatment of HR+, HER2-, advanced breast cancer
- NDA was supported by data from PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs fulvestrant in HR+/HER2- advanced breast cancer pts
- Trial showed that gedatolisib + fulvestrant & palbociclib reduced the risk of disease progression or death by 76% (mPFS: 9.3 vs 2mos.), while gedatolisib + fulvestrant reduced the risk by 67% (mPFS: 7.4 vs 2mos.)
Ref: GlobeNewswire | Image: Celcuity | Press Release
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