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FDA Approves FoundationOne® Liquid CDx as Companion Diagnostic for Itovebi™ (inavolisib) to Identify Hormone Receptor-Positive, HER2-Negative Breast Cancer Patients with PIK3CA Mutation

NextEdge Admin

11 Oct 2024

2 min 16 sec

Foundation Medicine, Inc. has announced FDA approval for FoundationOne® Liquid CDx as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant. This therapy, developed by Genentech, targets adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer, following recurrence after adjuvant endocrine therapy.

Approximately 70% of breast cancers are hormone receptor-positive and HER2-negative, with PIK3CA mutations present in around 40% of these patients. “This approval emphasizes the importance of PIK3CA mutation testing at diagnosis to guide first-line treatment decisions for metastatic breast cancer patients,” stated Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. The liquid biopsy diagnostic, requiring only a routine blood draw, improves access to genomic testing and enables more patients to benefit from this new first-line treatment regimen.

Foundation Medicine is the only company with an FDA-approved portfolio of both tissue and blood-based comprehensive genomic profiling tests. FoundationOne Liquid CDx analyzes over 300 cancer-related genes from a simple blood sample, reinforcing the company’s leadership in companion diagnostics with seven breast cancer indications.

“Given the high prevalence of PIK3CA mutations in this patient population, the introduction of a new targeted treatment regimen will significantly impact outcomes,” said Jean A. Sachs, MSS, MLSP, CEO of Living Beyond Breast Cancer. The expansion of approved companion diagnostics plays a crucial role in personalized treatment decisions for patients and their families.