By Paul Ziobro

Roche Group unit Genentech said that the Food and Drug Administration approved Itovebi for treating certain breast cancer.

The approval is for Itovebi in combination with palbociclib and fulvestrant and for treating adults a certain locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

The approval comes after a Phase III study showed that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with palbociclib and fulvestrant alone in the first-line setting.

Write to Paul Ziobro at paul.ziobro@wsj.com


(END) Dow Jones Newswires

10-10-24 1657ET