FDA Approves the First Pan-Tumour Comprehensive Genomic Profiling Assay
The US Food and Drug Administration (FDA) has approved FoundationOne CDx, Foundation Medicine’s comprehensive companion diagnostic assay for personalised oncology care1. FoundationOne CDx supports physicians in clinical decision-making by providing a report that describes the unique genomic profile of the patient’s tumour as well as associated approved therapies and relevant clinical trial information. FDA approval of this assay, based on its clinical and analytical validation, now means the service can be used as a companion diagnostic for therapy selection when people have been diagnosed with solid tumours.
Roche acquired a majority stake in the company in 2015. Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development said, “The approval of FoundationOne CDx represents a major advance in the personalisation of cancer care, facilitating access for patients in the US to a comprehensive pan-tumour companion diagnostic that will help identify approved treatment options based on the molecular footprint of each individual’s cancer,” she added, “Our belief is that profiling will increasingly become routine in clinical practice, so we have worked closely with Foundation Medicine to develop an extensive clinically and analytically validated platform that can support both existing and future companion diagnostic needs.”
FoundationOne CDx is the first FDA-approved pan-tumour comprehensive companion diagnostic assay to:
- Assess all four classes of genomic alterations in 324 genes known to drive cancer growth, providing information to help guide the decisions of treating physicians;
- identify patients with advanced cancer who are likely to respond to targeted therapies, based on their individual genomic profile; and,
- Report genomic signatures, including microsatellite instability (MSI) and tumour mutational burden (TMB), and report genomic alterations in other genes [relevant to other therapies] for use by physicians for patient management according to professional guidelines in oncology.
Of the 17 therapies currently approved for inclusion in the report, twelve are approved as first-line treatment options for their respective indications. The number of on-label targeted therapies in the report is expected to increase over time as Foundation Medicine and its partners gain FDA approval for additional biomarkers on the platform.
The approval of FoundationOne CDx also represents the first next generation sequencing (NGS)-based companion diagnostic for Alecensa® (alectinib), an FDA-approved monotherapy for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)2. Alecensa is approved in both the front-line setting and for people who have progressed on or are intolerant to crizotinib. Including ALK-rearrangements in a larger comprehensive panel may ensure that more patients are identified and eligible for treatment based on their ALK-positive status.