Roche has announced that the US FDA has accepted its New Drug Application (NDA) for giredestrant in combination with everolimus.[1][2][4] This oral treatment is indicated for adult patients with estrogen receptor-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer after prior endocrine therapy.[1][2][4] The acceptance of the application is based on the results of the Phase III evERA trial, where the combination of giredestrant and everolimus reduced the risk of disease progression or death by 44% in the overall population (ITT) and by 62% in patients with ESR1 mutations compared to standard endocrine therapy with everolimus.[1][2][4] In patients with ESR1 mutations, the median progression-free time was 9.99 months in the giredestrant arm versus 5.45 months in the control arm.[2] In the ITT population, the median progression-free time was 8.77 months versus 5.49 months.[2] The FDA has set a decision date under the Prescription Drug User Fee Act for December 18, 2026.[1][2][4][5] If approved, this could be the first oral selective estrogen receptor degrader (SERD) combination in the post-CDK4/6 inhibitor setting.[1][2][4]