Shots:
The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy
NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…
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…

