Australia Launches Genomics Australia to Lead Advances in Genomic Medicine

Sidra Medicine Unveils Masterclasses Ahead of PMFG 2024 Summit

FDA Approves Revuforj® as First Menin Inhibitor for Acute Leukemia with KMT2A Translocation

CHMP Recommends Approval of Opdivo® Plus Yervoy® for First-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer

ADDF Invests $1.18M to Standardize p-tau217 Blood Tests for Alzheimer’s Diagnosis

GSK Reports Positive Interim Results for DREAMM-7 Trial of Blenrep in Multiple Myeloma

Molbio Diagnostics Invests $30 Million in OptraSCAN to Revolutionize Digital Pathology

BioNTech Acquires Chinese Oncology Firm Biotheus for $950M

The Care and Protection of Children Trust

CPCT Launches Groundbreaking Initiative to Provide Lifelong Free Treatment for Children with Spinal Muscular Atrophy (SMA) in Karnataka

Early Comprehensive Genomic Profiling Improves Cancer Treatment Outcomes, Study Shows

EMA Reverses Decision, Recommends Limited Approval for Eisai and Biogen’s Alzheimer’s Drug Leqembi

Exact Sciences Unveils Advances in Multi-Cancer Early Detection with Cancerguard™ Test

MSD and LaNova Medicines Enter Exclusive Global License Agreement for Novel Cancer Therapy, LM-299

Promising CAR T Cell Therapies from BMS and Cabaletta Bio Show Potential for Durable Remission in Severe Lupus

FDA Grants Accelerated Approval to PTC Therapeutics' KEBILIDI™, the First Gene Therapy for AADC Deficiency in the U.S.

Home
/
update
/
details

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.