Roche Holding AG (RHHBY) announced that the FDA has accepted its new drug application (NDA) seeking approval for its investigational oral therapy inavolisib for treating adult patients with breast cancer. The NDA is seeking approval for inavolisib in combination with Pfizer’s (PFE) Ibrance (palbociclib) and AstraZeneca’s (AZN) Faslodex (fulvestrant) to treat adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER)-negative, locally advanced/metastati ...