As the most common mutation in HR+/HER2- aBC, it’s important to test for PIK3CA mutations early on during the initial MBC workup.2 With 3 FDA-approved testing modalities, you have multiple options for learning their PIK3CA mutation status.2,3
Per NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®), test for PIK3CA mutations as part of the initial MBC workup if all the following are true5:
✓ Patient has recurrent/Stage IV (M1) disease
✓ Tumor is HR+/HER2-
✓ Considering therapy with alpelisib + fulvestrant*
The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way. *Following progression on or after an endocrine-based regimen.
Guidelines state that PIK3CA mutation status should be considered when evaluating treatment options for patients who have progressed on their first-line MBC therapy5
PIQRAY is indicated for adults, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer (aBC or MBC), in combination with fulvestrant following progression on or after an endocrine-based regimen.
MBC, metastatic breast cancer. *Following progression on or after an endocrine-based regimen. †If liquid biopsy is negative, tumor tissue testing is recommended. ‡The safety of alpelisib in patients with type 1 or uncontrolled type 2 diabetes has not been established. §Unless a recurrence or unmanageable toxicity occurs, per HR+/HER2- MBC American Society of Clinical Oncology® Guideline Update 2021.
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
Foundation Medicine's FoundationOne®CDx and FoundationOne®Liquid CDx are comprehensive genomic profiling (CGP), next-generation sequencing (NGS) multi-gene tests, which include PIK3CA, and provide tissue and plasma testing, respectively.2,3
Multi-gene NGS test from Foundation Medicine
FoundationOne®CDx tissue-based
FoundationOne®CDx is a comprehensive genomic profiling (CGP) next-generation sequencing (NGS)-based multi-gene in vitro diagnostic test. FoundationOne®CDx can detect PIK3CA mutations in tissue and is a companion diagnostic for alpelisib.2
FoundationOne®CDx and FoundationOne®Liquid CDx are covered by Original Medicare and Medicare Advantage for qualifying beneficiaries
Results can be found on page 1 of the sample report.
Foundation Medicine offers in-home blood draw with mobile phlebotomy through its partner, ExamOne®, to support broader access to FoundationOne®Liquid CDx, at no additional cost.
Foundation Medicine generally expects to provide results in 12 days or less from specimen receipt.
FoundationOne®Liquid CDx is a comprehensive genomic profiling (CGP) next-generation sequencing (NGS)-based multi-gene in vitro diagnostic test. FoundationOne®Liquid CDx can detect PIK3CA mutations in blood and is a companion diagnostic for alpelisib. Foundation Medicine offers the option to automatically reflex between tissue and liquid sample types.3
FoundationOne®CDx and FoundationOne®Liquid CDx are covered by Original Medicare and Medicare Advantage for qualifying beneficiaries12
Results can be found on page 1 of the sample report.
Foundation Medicine offers in-home blood draw with mobile phlebotomy through its partner, ExamOne®, to support broader access to FoundationOne®Liquid CDx, at no additional cost.
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Foundation Medicine generally expects to provide results in 12 days or less from specimen receipt.
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.
Severe Hypersensitivity:Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, can occur in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms, including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia...
Indication
PIQRAY® (alpelisib) tablets is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen...