FDA Approves Gedatolisib in Breast Cancer

In VIKTORIA-1, gedatolisib-containing regimens resulted in longer median progression-free survival than fulvestrant alone.

1

The FDA approved gedatolisib for adults with hormone receptor-positive, HER2-negative breast cancer after endocrine therapy progression.
2

Efficacy was evaluated in the VIKTORIA-1 trial, which enrolled 392 patients with advanced or metastatic breast cancer.
3

Median progression-free survival was 9.3 months for gedatolisib, fulvestrant, and palbociclib compared to 2.0 months for fulvestrant alone.
4

Objective response rates were 32% with the three-drug regimen and 28% with gedatolisib and fulvestrant, versus 1% with fulvestrant alone.
5

Warnings include stomatitis, dermatologic reactions, hyperglycemia, and embryo-fetal toxicity; the recommended dosage is 180 mg weekly.

1