Global pharma powerhouse Roche has announced that the US FDA has accepted its New Drug Application (NDA) for an investigational oral therapy for patients with advanced breast cancer.

 

The acceptance is for giredestrant in combination with everolimus for adults with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following progression on prior endocrine therapy. The FDA is expected to reach a decision by 18 December 2026.

 

If approved, giredestrant plus everolimus could become the first oral selective estrogen receptor degrader (SERD) combination available for patients in the post-CDK4/6 inhibitor setting.

 

“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,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “This acceptance marks a first step towards establishing the giredestrant combination as a new standard of care in this population.”

 

The NDA filing is supported by results from the phase III evERA Breast Cancer study. The trial showed giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the intention-to-treat population and by 62% in patients with ESR1 mutations, compared with standard endocrine therapy plus everolimus.

 

ER-positive breast cancer accounts for roughly 70% of breast cancer cases, with resistance to endocrine therapies in the post-CDK inhibitor setting driving poor outcomes. Oral combination therapies like giredestrant plus everolimus may address this by targeting multiple signaling pathways while sparing patients from injections.

 

“The extensive giredestrant clinical development programme spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible,” the company said.