US Food and Drug Administration Approval Summary: Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, Locally Advanced or Metastatic Breast Cancer.

doi:10.1200/JCO-25-00663

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US Food and Drug Administration Approval Summary: Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, Locally Advanced or Metastatic Breast Cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 1 Oct 2025

Wedam Suparna, Narayan Preeti, Gittleman Haley, Cheng Joyce, Bhatnagar Vishal, Sabit Hairat, Price Lauren S L, Rahman Nam Atiqur, Chiu Haw-Jyh, Biel Nikolett, Ricks Tiffany, Fiero Mallorie, Tang Shenghui, Osgood Christy, Pierce William, Pazdur Richard, Kluetz Paul G, Amiri-Kordestani Laleh

Abstract excerpt

PURPOSE: The US Food and Drug Administration (FDA) approved inavolisib with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer (MBC), as detected by an FDA-approved test, FoundationOne Liquid CDx assay, after recurrence on or after completing adjuvant...

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PMID: 40845250
DOI: 10.1200/JCO-25-00663

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PIK3CA

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US Food and Drug Administration Approval Summary: Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, Locally Advanced or Metastatic Breast Cancer.PMID 40845250Read ↗

Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer.Semantic proximity Read ↗

Inavolisib for HR-Positive, HER2-Negative Advanced Breast Cancer: Clinical Trials and Patient Access Implication.Semantic proximity Read ↗

Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer.Semantic proximity Read ↗

Safety analyses of the INAVO120 randomised phase III trial of inavolisib or placebo with palbociclib-fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer.Semantic proximity Read ↗

Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer.Semantic proximity Read ↗

Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.Semantic proximity Read ↗

Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor-Positive Advanced Breast Cancer.Semantic proximity Read ↗

PI3Kα Inhibitor and Degrader Inavolisib Can Co-opt FGFR2 to Enhance Responses in Patients with PIK3CA-Mutated Solid Tumors and in Preclinical Models.Semantic proximity Read ↗

Inavolisib: a second-generation PI3Kα inhibitor in HR+/HER2-negative breast cancer.Semantic proximity Read ↗

FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer.Semantic proximity Read ↗

Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1.Semantic proximity Read ↗

Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial.Semantic proximity Read ↗

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