FDA Grants Fast Track Designation to Innocrin Pharmaceuticals’ Seviteronel

Innocrin Pharmaceuticals has received its second fast track designation for seviteronel (VT-464).

The new designation is for the treatment of women with advanced androgen receptor-positive triple-negative breast cancer and women or men with advanced estrogen receptor-positive breast cancer.

Seviteronel selectively inhibits CYP17 lyase, an enzyme needed for the synthesis of androgens and estrogens, and also directly blocks the receptor.

Seviteronel is a once-daily oral therapeutic given without prednisone.