Roche's Itovebi Gains FDA Approval, Targets Breast Cancer Market with $2.3B Sales Projection

The FDA has granted approval for Roche's inavolisib, now branded as Itovebi, as a first-line treatment for specific breast cancer patients, marking a significant milestone for the company's oncology portfolio[1][2]. Itovebi is approved for patients with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer and is administered alongside Pfizer’s Ibrance and AstraZeneca’s Faslodex[1]. The approval was bolstered by data from the Phase III INAVO120 study, which demonstrated a 57% reduction in disease progression risk. This positions Itovebi as a formidable competitor in the market, challenging existing treatments like Novartis' Piqray[1][2].