Novartis Piqray® Approved for Patients with a PIK3CA Mutation in HR+/HER2- Advanced Breast Cancer Interview with:

Fabrice André, MD, PhD Research director and head of INSERM Unit U981 Professor in the Department of Medical Oncology Institut Gustave Roussy in Villejuif, France Global SOLAR-1 Principal Investigator.

Dr. Fabrice André

Fabrice André, MD, PhD
Research director and head of INSERM Unit U981
Professor in the Department of Medical Oncology
Institut Gustave Roussy in Villejuif, France
Global SOLAR-1 Principal Investigator. What is the background for this study? How does Piqray®  differ from other treatments for this type of advanced breast cancer? 

  • The US Food and Drug Administration (FDA) approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test after disease progression following an endocrine-based regimen.
  • Piqray is the first and only combination treatment with fulvestrant specifically for postmenopausal women, and men, with HR+/HER2- advanced or metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen, bringing a biomarker-driven therapy option to this population for the first time.
  • Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may be eligible for treatment with Piqray plus fulvestrant combination therapy. When might Piqray® be available for clinical use?

Piqray will be available in both specialty and retail pharmacies in the United States. Piqray is currently available to patients commercially.

  • Piqray was approved with a companion diagnostic test, the QIAGEN N.V. therascreen* PIK3CA RGQ PCR companion diagnostic tissue tests, to detect the presence of a PIK3CA mutation. The therascreen test is capable of analyzing new or archived tissue and/or plasma samples. If no mutation is detected in a plasma specimen, test tumor tissue.  Oncologists sending a tumor biopsy for analysis can now opt to test for a PIK3CA mutation. The Current Procedural Terminology (CPT) code will be available for billing in January 2020. In the interim, between the launch of Piqray and January of 2020, T2 Code 81404 can be used by labs to submit claims for reimbursement. What should readers take away from your report? 

  • With the approval of Piqray, PIK3CA mutation testing is now a critical component of managing care for advanced breast cancer. Findings of these biomarker tests may be used to inform treatment decisions.
  • PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation. PIK3CA mutations are associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis. c Is there anything else you would like to add?

  • Novartis also has entered into an agreement with Foundation Medicine to develop flexible companion diagnostic solutions for Piqray that utilize both tumor tissue and plasma sample types.
  • Andre disclosed financial relationships with Novartis, AstraZeneca, Pfizer, Lilly, Roche and Daiichi Sankyo. 


FDA has approved Novartis Piqray® – for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.

Jun 3, 2019 @ 12:15 pm 

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