SOUTH SAN FRANCISCO (dpa-AFX) - Swiss drug major Roche Holding AG (RHHBY, RO.SW, ROG.SW) announced Thursday that giredestrant combination significantly improved progression-free survival in ER-positive advanced breast cancer in phase III evERA.
The detailed results from the evERA Breast Cancer study were published in The New England Journal of Medicine.
The FDA has set a PDUFA goal date for giredestrant in early-stage breast cancer of November 30 and in advanced disease of December 18.
giredestrant is an investigational oral selective oestrogen receptor degrader or SERD.
The evERA trial is evaluating giredestrant in combination with everolimus in people with oestrogen receptor (ER)-positive locally advanced or metastatic breast cancer who had disease progression or recurrence following treatment with a cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy.
According to the firm, the giredestrant combination seeks to delay disease progression and improve overall patient outcomes by targeting resistance to endocrine treatments.
The company reported that investigational giredestrant in combination with everolimus significantly improved progression-free survival or PFS versus standard endocrine therapy plus everolimus.
Additional evERA analyses were presented at the 2026 American Society of Clinical Oncology Annual Meeting. The date showd that giredestrant plus everolimus prolongs PFS2 (time from randomisation to disease progression following second-line therapy) and chemotherapy-free survival compared with standard endocrine therapy. This suggests that the clinical benefit may be sustained beyond initial progression.
Erica Mayer, Medical Oncologist at Dana-Farber Cancer Institute, stated, 'The evERA trial demonstrated that the giredestrant combination significantly delayed disease progression, potentially offering a promising all-oral treatment option in a setting where there remains a need for additional treatments to improve patient outcomes.'
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