US Food and Drug Administration Approval Summary: Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, <i>PIK3CA</i> -Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative, Locally Advanced or Metastati
The approval of inavolisib with palbociclib plus fulvestrant was based on a statistically significant and clinically meaningful improvement in PFS observed in the INAVO120 trial. Before this approval, there were no specific therapies approved by the FDA for the first-line treatment of patients with endocrine-resistant, hormone receptor-positive advanced or MBC.
Authors
- Nam Atiqur Rahman (ORCID: https://orcid.org/0009-0001-0002-7006)
- Nikolett M. Biel
- Haw-Jyh Chiu
- Christy Osgood (ORCID: https://orcid.org/0000-0001-7450-9342)
- Haley Gittleman (ORCID: https://orcid.org/0000-0002-6976-8777)
- Shenghui Tang (ORCID: https://orcid.org/0000-0002-0437-665X)
- Joyce Cheng (ORCID: https://orcid.org/0009-0006-0630-9844)
- William F. Pierce (ORCID: https://orcid.org/0000-0002-3411-7720)
- Richard Pazdur (ORCID: https://orcid.org/0000-0002-4771-9923)
- Paul G. Kluetz (ORCID: https://orcid.org/0000-0002-9796-4791)
- Laleh Amiri‐Kordestani (ORCID: https://orcid.org/0000-0002-0056-5437)
- Lauren Price (ORCID: https://orcid.org/0000-0001-7810-0499)
- Preeti Narayan (ORCID: https://orcid.org/0000-0003-0825-9087)
- Vishal Bhatnagar (ORCID: https://orcid.org/0000-0003-4650-0513)
- Tiffany K. Ricks
- Suparna Wedam (ORCID: https://orcid.org/0000-0003-0455-5399)
- Mallorie H. Fiero (ORCID: https://orcid.org/0000-0001-5536-116X)
- Hairat Sabit
Institutions
- United States Food and Drug Administration (US)
- Center for Drug Evaluation and Research (US)
- Ohio Department of Health (US)
Publication Details
- Journal
- Journal of Clinical Oncology
- Published
- 2025-08-22
- DOI
- https://doi.org/10.1200/jco-25-00663
- Citations
- 3
- Primary Topic
- Advanced Breast Cancer Therapies
- Type
- article
- Field-Weighted Citation Impact
- 4.56