Posted by Michael Wonder on 15 Nov 2017
Faslodex (fulvestrant) receives EU approval for the treatment of hormone receptor-positive advanced breast cancer in combination with palbociclib
14 November 2017 - First EU approval for fulvestrant in combination with a CDK4/6 inhibitor.
AstraZeneca today announced that the European Commission has approved a new indication for Faslodex (fulvestrant) in combination with a CDK4/6 inhibitor, palbociclib, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
The EU approval is based on data from the Phase III PALOMA-3 trial, which showed a statistically significant increase in investigator-assessed median PFS of 4.9 months (9.5 months vs 4.6 months) in patients who received fulvestrant 500 mg and palbociclib 125 mg over fulvestrant and placebo (HR: 0·46; 95% CI: 0·36–0·59; p<0·0001).
