Guardant Health, Inc. Receives FDA Approval as First and Only Liquid Biopsy Companion Diagnostic for Amgen’s LUMAKRAS™ KRASG12C Inhibitor for Use in Advanced Non-Small Cell Lung Cancer
May 28, 2021 at 01:15 pm EDT
Share
Guardant Health, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Guardant360® CDx test as the first and only liquid biopsy companion diagnostic for tumor mutation profiling, or comprehensive genomic profiling, to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation and may benefit from LUMAKRAS™ (sotorasib), an FDA-approved KRASG12C inhibitor developed and manufactured by Amgen. The Guardant360 CDx FDA approval was based on clinical validation data from the CodeBreaK 100 trial evaluating sotorasib in patients with locally advanced or metastatic NSCLC. Patients identified with the KRAS G12C mutation using the Guardant360 CDx demonstrated an objective response rate consistent with those identified using traditional tissue-based biomarker testing. Lung cancer is the leading cause of cancer death in the U.S. and NSCLC accounts for approximately 84% of all lung cancers. It is estimated that 66% of patients with NSCLC have advanced or metastatic disease at initial diagnosis, and two out of three with lung adenocarcinoma harbor a driver mutation. Clinical guidelines recommend comprehensive genomic profiling at diagnosis, for all patients with advanced NSCLC, to evaluate whether they have one of the growing list of actionable and emerging biomarkers with associated treatment options. KRAS G12C is one of the most common driver mutations in NSCLC, occurring in 13% of patients, and until now, FDA-approved targeted therapy options did not exist In the CodeBreaK 100 phase 2 clinical trial, which was the basis for the FDA approval, sotorasib demonstrated compelling efficacy and tolerability in patients with KRAS G12C-mutated non-small cell lung cancer. This approval represents a historic milestone for patients with this mutation. This new targeted therapy, reinforces once again why comprehensive biomarker testing at diagnosis is critical. Having additional options, including the availability of a blood-based testing option, such as the Guardant360 CDx, will help to more quickly identify the patients who may benefit and help guide treatment decisions. For oncologists, the FDA-approved Guardant360 CDx provides comprehensive genomic results from a simple blood draw in seven days, helping them move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment. Guardant360 CDx covers all genes recommended by the National Comprehensive Cancer Network, including those most relevant to clinical care and NSCLC treatment guidelines. Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling with more than 200 peer-reviewed publications. It has been trusted by more than 9,000 oncologists, with more than 150,000 tests performed to date, and is broadly covered by Medicare and many private payers, representing over 200 million lives.
Guardant Health, Inc. is a precision oncology company focused on guarding wellness and giving every person more time free from cancer. It provides critical insights into what drives disease through its advanced blood and tissue tests, real-world data, and artificial intelligence (AI) analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For patients with advanced-stage cancer, it has developed Guardant360 laboratory developed test (LDT), and Guardant360 CDx, a comprehensive liquid biopsy test to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer (NSCLC), and breast cancer. It offers other tests, including Guardant360 TissueNext tissue test, Guardant Reveal blood test, Guardant360 Response blood test and others.
Guardant Health, Inc. Receives FDA Approval as First and Only Liquid Biopsy Companion Diagnostic for Amgen’s LUMAKRAS™ KRASG12C Inhibitor for Use in Advanced Non-Small Cell Lung Cancer