RHHBY - Roche Cancer Drug Gets Breakthrough Therapy Designation | Benzinga
Roche (OTC: RHHBY) obtained a Breakthrough Therapy Designation for its investigational oral therapy inavolisib for treating adult breast cancer patients in the United States.
The FDA granted this designation to inavolisib in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) to treat adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2 (HER)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
HR-positive breast cancer is the most prevalent type of breast cancer and roughly accounts for approximately 70% of cases.
The designation is based on phase III INAVO120 study results, which showed that the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting. The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm. Overall survival data were immature at this time, but a clear positive trend has been observed.
Breakthrough Therapy Designation accelerates the development and regulatory review of drugs that are intended to treat fatal disease conditions where preliminary clinical evidence has indicated they may demonstrate substantial improvement over ...