Shots:
- The US FDA has received sNDA for Revtorpyk (gedatolisib) for the treatment of pts with HR+, HER2-, locally advanced or metastatic breast cancer with a PIK3CA mutation, following progression on or after treatment with ≥1L of endocrine therapy
- sNDA was supported by the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of Revtorpyk + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor
- In the cohort, the Revtorpyk triplet improved PFS by 50% & showed mPFS of 11.1 vs 5.6mos., ORR of 49% & an mDOR of 15.7mos. Revtorpyk doublet improved PFS by 49% & showed mPFS of 11.3 vs. 5.6mos., with an ORR of 36% & mDOR of 24.2mos.
Ref: Globenewswire | Image: Celcuity | Press Release
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