FDA Breakthrough status for Roche’s inavolisib

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for inavolisib.

Under development by Swiss pharma giant Roche (ROG:SIX), inavolisib is an investigational oral therapy, used in combination with Pfizer’s (NYSE: PFE) Ibrance (palbociclib), plus fulvestrant, marketed by AstraZeneca (LSE: AZN) under the Faslodex brand, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.

“We are pleased that the FDA granted Breakthrough Therapy Designation for inavolisib in recognition of the substantial clinical benefit observed with this regimen,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “This promising inavolisib-based regimen could transform the PI3K inhibitor class, potentially becoming the standard of care for this patient population in the first-line setting,” he noted.