Roche has obtained acceptance from the US Food and Drug Administration (FDA) for its new drug application (NDA) submitted for giredestrant, an oral therapy, along with everolimus to treat breast cancer.
The submission targets adult patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer that has progressed after previous endocrine-based therapy.
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The FDA decision is anticipated by 18 December 2026.
Giredestrant plus everolimus for breast cancer is expected to become the first oral selective oestrogen receptor degrader (SERD) combination cleared for this indication in the cyclin-dependent kinase (CDK) 4/6 inhibitor setting.
The NDA acceptance is based on results from the Phase III evERA Breast Cancer study, which demonstrated that combining giredestrant with everolimus reduced the risk of disease progression or death by 44% in the intention-to-treat (ITT) population and by 62% among patients with ESR1 mutations, when compared to standard endocrine therapy combined with everolimus.
In ESR1-mutated patients, median progression-free survival (PFS) was 9.99 months for the giredestrant arm versus 5.45 months for comparators. In the ITT group, median PFS was 8.77 months versus 5.49 months in the giredestrant and comparator arms.
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By GlobalDataRoche chief medical officer and global product development head Levi Garraway said: “The clinically meaningful benefit seen with giredestrant could enable an important new treatment option to help delay disease progression or death in people with advanced, ER-positive breast cancer. This acceptance marks a first step towards establishing the giredestrant combination as a new standard of care in this population.”
Roche plans further submissions of Phase III lidERA data worldwide and expects readout from persevERA in first-line ER-positive breast cancer later this year.
In November 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted approval to Roche’s Itovebi (inavolisib) to treat adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
