Roche's giredestrant has received FDA acceptance for a New Drug Application in combination with everolimus for treating ER-positive, ESR1-mutated advanced breast cancer.

Roche's giredestrant has received FDA acceptance for a New Drug Application in combination with everolimus for treating ER-positive, ESR1-mutated advanced breast cancer. Phase III trial data demonstrates the combination reduced disease progression or death risk by 44% in the broader patient population and 62% in ESR1-mutated patients compared to standard endocrine therapy. This could represent the first oral selective estrogen receptor degrader combination approved in the post-CDK4/6 inhibitor setting, potentially establishing a new treatment standard. The FDA is expected to make a final decision by December 18, 2026, marking a significant development in Roche's oncology pipeline and addressing resistance to existing therapies.