Roche has submitted a new drug application (NDA) to US regulatory authorities for its oral selective estrogen receptor degrader (SERD), giredestrant, in combination with everolimus. The application is for the treatment of postmenopausal women and men with ESR1-mutated, ER+/HER2- locally advanced or metastatic breast cancer whose disease has progressed on prior endocrine therapy. The institution set an action date of 18 December 2026. If approved, the regimen would be the first all-oral SERD therapy option for this patient population following progression on a CDK4/6 inhibitor.

The submission is supported by positive results from the Phase III evERA trial, which demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS) for the combination compared to the control arm. The benefit was more pronounced in the subgroup of patients with ESR1 mutations. The safety profile was consistent with the known profiles of each drug. The application joins a competitive field for next-generation oral SERDs, with Eli Lilly's imlunestrant having already gained US approval in September 2025 for a similar patient population.

According to PharmCube's NextBiopharm® database, giredestrant ranks 5th globally among estrogen receptor degraders in terms of development. Click here to request a free trial for NextBiopharm®.