Launch
FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer
What's New: Drugs RSS Feed · By FDA ·
The Brief
- On October 10, 2024, the FDA approved inavolisib (Itovebi, Genentech) with palbociclib and fulvestrant.
- The approval covers adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer.
- The source describes the approval only; it reports no trial figures or outcome data.
Why it matters
It adds a targeted combination treatment option for a defined subgroup of advanced breast cancer patients, identified by PIK3CA mutation status and endocrine resistance.
Who’s affected
- Adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer
- #oncology
- #breast cancer
- #fda approval
- #targeted therapy
- #pik3ca
On October 10, 2024, the Food and Drug Administration approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative…