Posted by Michael Wonder on 15 Nov 2017
Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib
15 November 2017 - Faslodex in combination with abemaciclib showed 16.4 months of progression-free survival.
AstraZeneca today announced that the US FDA has approved a new indication for Faslodex (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in women with disease progression after endocrine therapy.
The FDA approval is based on data from the Phase III MONARCH 2 trial, which met the study’s primary endpoint of progression-free survival.
