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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

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…

Timeline

  1. FDA approves inavolisib with palbociclib and fulvestrant

  2. What's New: Drugs RSS Feed

    FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

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