Weekly Rundown: Genentech's oral breast cancer drug gets priority FDA review Pharma deals, FDA review hurdles, and more led the news this week. Written byDDN editorial team

https://www.drugdiscoverynews.com/weekly-rundown-genentech-s-oral-breast-cancer-drug-gets-priority-fda-review-17222 Genentech announced this week that the FDA has accepted its New Drug Application (NDA) for giredestrant under priority review, an investigational oral selective estrogen receptor degrader for adults with estrogen receptor (ER)-positive, HER2 (Human Epidermal growth factor Receptor 2)-negative early-stage breast cancer, with a decision expected November 30, 2026. The submission is based on results from the Phase 3 lidERA Breast Cancer study, which enrolled more than 4,100 patients and showed giredestrant reduced the risk of invasive disease recurrence or death by 30 percent compared with standard-of-care endocrine therapy. At three years, 92.4 percent of patients on giredestrant were alive and free of invasive disease versus 89.6 percent on standard therapy, with consistent benefit across all subgroups. The drug was also better tolerated, with a treatment discontinuation rate of 5.3 percent versus 8.2 percent on standard care. If approved, giredestrant would represent the first significant advance in adjuvant endocrine therapy for early-stage breast cancer in more than 20 years — a meaningful bar given that ER (Estrogen receptor)-positive disease accounts for roughly 70 percent of all breast cancer diagnoses and up to a third of early-stage patients eventually experience recurrence on current therapies. The FDA separately accepted a second Genentech NDA for giredestrant in combination with everolimus for advanced breast cancer with ESR1 (Estrogen Receptor 1) mutations, with that decision expected in December 2026. – Andrea Corona