Published on 29 May 2024 on Zacks via Yahoo Finance
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/metastatic breast cancer, after recurrence on or within 12 months of completing adjuvant endocrine treatment.