Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to palbociclib in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.

This is written in the approval document as:

IBRANCE is a kinase inhibitor indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.

Citation

Pfizer. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207103s024lbl.pdf. Revised June 2026. Accessed October 13, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative, PIK3CA oncogenic variants	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib
FDA (2)	HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib
FDA (2)	ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive	Invasive Breast Carcinoma	Fulvestrant, Inavolisib, Palbociclib

Contributions

Date	Contributor	Description
2026-10-13	Van Allen lab	Initial curation of this indication into moalmanac-db.
2026-06-24	Food and Drug Administration	Indication received traditional approval.