FDA reviews Roche giredestrant for early HR+ HER2- breast cancer
Roche's new drug, giredestrant, is in the spotlight as the FDA reviews it for early-stage, hormone receptor-positive, HER2-negative breast cancer.
The decision is expected by November 30, 2026.
Giredestrant works by blocking estrogen receptors and could lower the risk of the cancer coming back or causing death by about 30%.
Giredestrant everolimus trial cuts progression 44%
Giredestrant isn't just for early cases: it's also being tested with another medicine (everolimus) for advanced hormone-sensitive breast cancer.
Recent trial results are promising: risk of the cancer getting worse, or death, fell by 44% overall, and by 62% in patients whose cancer had stopped responding to hormone therapy because of a gene change called ESR1.
If it gets approved, this drug might really change how doctors treat both early and advanced breast cancer.