Genentech gets FDA acceptance for giredestrant combination new drug application

Genentech, a member of Roche (RHHBY), announced that the FDA has accepted the company’s new drug application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by December 18. Giredestrant plus everolimus could be the first and only oral selective estrogen receptor degrader (SERD) combination approved in the post-cyclin-dependent kinase 4/6 inhibitor setting.