Roche：Giredestrant receives FDA filing acceptance
On June 2, it was announced that the supplemental New Drug Application (sNDA) for Roche’s core investigational SERD product Giredestrant, for a new indication, has been accepted by the FDA. The new indication targets adjuvant treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2026.
Giredestrant, Roche’s next-generation oral SERD developed in-house, possesses complete estrogen receptor antagonistic activity. Through its dual mechanism of blocking estrogen binding to the ER target and promoting receptor degradation, it achieves inhibition of breast tumor cell proliferation.
Previously, in February 2026, based on key subgroup data from the Phase III evERA clinical trial, the drug submitted its first marketing application in the United States, seeking approval in combination with everolimus for the treatment of ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations in patients who have failed prior endocrine therapy. According to available information, for the same indication in China, the drug was submitted for marketing for the first time on April 16 of this year.
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