Currently Viewing:
Currently Reading
Can Rituximab Delay Disease Progression in SPMS?
January 19, 2019 – Samantha DiGrande
Tumor Mutational Burden Predicts Who Will Respond to Immunotherapy
January 19, 2019 – Jaime Rosenberg
Once-Weekly Carfilzomib Improves PFS, OS in High-Risk Patients With MM Over Twice-Weekly Dose
January 19, 2019 – Laura Joszt
PCT Just as Effective as MASCC for Predicting Serious Complications in Febrile Neutropenia
January 18, 2019 – Jaime Rosenberg
Researchers Document Links Between Pollution Levels, ED Visits for Breathing Problems
January 18, 2019 – Allison Inserro
CMS Expands VBID in Medicare Advantage, Increases Risk Sharing in Part D
January 18, 2019 – Allison Inserro
Tracking Medicaid Expansion
January 18, 2019 – AJMC Staff
This Week in Managed Care: January 18, 2019
January 18, 2019
USPSTF Releases Draft Recommendation on Drugs to Lower Risk of Breast Cancer
January 18, 2019 – Samantha DiGrande

FDA Approves NGS-Based Test That Detects Very Low Levels of Cancer Cells in ALL or MM

Laura Joszt
A test that uses next-generation sequencing (NGS) has been approved to detect and monitor minimal residual disease in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL).
A test that uses next-generation sequencing (NGS) has been approved to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL). The clonoSEQ Assay assesses disease burden to predict treatment outcomes, guide management decisions, and improve patient care.

Gottlieb called the approval an “important step forward for patients suffering from ALL and multiple myeloma.”

Approximately 6000 people in the United States will be diagnosed with ALL and 31,000 will be diagnosed with MM in 2018, according to FDA. MRD refers to very low levels of remaining cancer cells remaining after treatment. Despite causing no symptoms, these residual cells can lead to a recurrence of the disease and can only be identified by highly sensitive tests.
“Determining whether a patient has residual cancer cells remaining after treatment provides information on how well a patient has responded to therapy and how long remission may last,” Gottlieb said in a statement. “Having a highly sensitive test available to measure minimal residual disease in ALL or multiple myeloma patients can help providers manage their patients’ care. The FDA is applying novel regulatory approaches to make sure that these rapidly evolving NGS tests are accurate and reliable.”

The FDA reviewed clonoSEQ assay through the de novo premarket review pathway, for novel, low- to moderate-risk devices. The agency used samples from 3 clinical trials including 273 patients with ALL, an ongoing trial of 323 patients with MM, and another study of 706 patients with MM. ClonoSEQ found that MRD level correlated with event-free survival in patients with ALL. Patients with a negative result had longer event-free survival, while patients with a higher MRD assay result had lower event-free survival. In patients with MM, the assay showed similar associations with progression-free survival and disease-free survival.

“The FDA clearance of clonoSEQ is an important advance for patients with MM and ALL and for the oncologists who care for them,” Aaron Logan, MD, PhD, associate professor, Division of Hematology and Blood and Marrow Transplant, University of California, San Francisco, said in a statement. “This milestone underscores the importance of MRD as a predictor of patient outcomes.”

Related Articles

FDA Finalizes Guidances to Accelerate Development of Next-Generation Sequencing Tests
Dr Peter Paul Yu: How Next-Generation Sequencing Is Changing Cancer Care
AI Platform Can Identify Personalized Drug Combinations to Treat Multiple Myeloma
Researchers Identify New Cancer Cell That Is Key to Relapse in AML
Single Resistant Cell Causes Case of Rare ALL Relapse After CAR T Therapy
Copyright AJMC 2006-2018 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
Welcome the the new and improved, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up

Sign In

Not a member? Sign up now!