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

Source: [What's New: Drugs RSS Feed](http://www.fda.gov/drugs/cancer-approvals/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive) · 2026-11-07 · Medicine
Page: https://themorning.science/story/fda-approves-inavolisib-with-palbociclib-and-fulvestrant-for-endocrine-resistant-34733adf86a810e6
Kind: launch · Impact: medium

## In 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.

## Timeline

- 2024-10-10: FDA approves inavolisib with palbociclib and fulvestrant

## Coverage

- [FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer](http://www.fda.gov/drugs/cancer-approvals/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive) — What's New: Drugs RSS Feed, 2026-11-07

Tags: oncology, breast cancer, fda approval, targeted therapy, pik3ca

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Brief generated by AI (claude-haiku-5-5) from the reporting listed under Coverage. Headlines belong to their publishers. The Morning Science – https://themorning.science