Foundation Medicine, Inc. has announced FDA approval for FoundationOne® Liquid CDx as a companion diagnostic for Itovebi™ (inavolisib) when used with palbociclib (Ibrance®) and fulvestrant. This therapy, developed by Genentech, is designed for adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer, identified by an FDA-approved test after recurrence following adjuvant endocrine therapy.
Approximately 70% of breast cancers are hormone-receptor positive and HER2-negative, with the PIK3CA gene being the most commonly mutated, affecting around 40% of these patients.
“This approval emphasizes the importance of testing for PIK3CA mutations at diagnosis, aiding treatment decisions for metastatic breast cancer patients,” said Mia Levy, M.D., Ph.D., Chief Medical Officer at Foundation Medicine. “Our liquid biopsy companion diagnostic, which uses a simple blood draw, increases access to genomic testing, allowing more patients to benefit from this advanced first-line treatment regimen.”
Foundation Medicine stands out as the only company with FDA-approved comprehensive genomic profiling tests for both tissue and blood. FoundationOne® Liquid CDx analyzes over 300 cancer-related genes from a routine blood sample, providing essential genomic insights.
With this new approval, Foundation Medicine now holds seven companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company. The firm leads in approved companion diagnostics, accounting for over 60% of U.S. indications for next-generation sequencing (NGS) testing.
“Considering the high prevalence of PIK3CA mutations in hormone receptor-positive, HER2-negative breast cancer, this new targeted treatment regimen will significantly impact this patient population,” stated Jean A. Sachs, MSS, MLSP, CEO of Living Beyond Breast Cancer. “Biomarker testing is crucial for helping patients make informed treatment decisions, and it’s encouraging to see Foundation Medicine expand its diagnostic indications in breast cancer.”
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a leader in molecular profiling for cancer, collaborating with various partners to set standards in quality and scientific excellence. Our insights into cancer biology support informed treatment decisions and drive the development of new therapies. For more information, visit Foundation Medicine and follow us on LinkedIn and X.
About FoundationOne® Liquid CDx
FoundationOne® Liquid CDx is an FDA-approved, next-generation sequencing diagnostic test that analyzes 324 genes using circulating cell-free DNA (cfDNA) from blood samples. It identifies patients who may benefit from specific therapies but does not guarantee a match. Negative results do not exclude the presence of mutations, and further tumor tissue testing may be necessary if companion diagnostic mutations are not found.
