FDA Gives Novartis PROS Drug Vijoice Accelerated Approval

The FDA has granted Novartis’ kinase inhibitor drug Vijoice (alpelisib) accelerated approval for patients two years and older who have severe forms of phosphatidylinositol 3-kinase (PI3KCA)-related overgrowth spectrum (PROS) disorder.

The approval was based on a retrospective study in which patients treated with Vijoice had a 27 percent response to treatment at week 24, which consisted of a 20 percent or greater reduction in the volume of lesions linked to the disorder.

Vijoice is the first FDA-approved treatment for PROS. However, another alpelisib drug, Novartis’ Piqray, was FDA-approved for patients with metastatic breast cancer in May 2019 — in combination with AstraZeneca’s Faslodex (fulvestrant).