Enhertu granted breakthrough therapy designation for patients with HER2-low metastatic breast cancer
June 2022—Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) in April was granted breakthrough therapy designation for treating patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed recurrence during or within six months of completing adjuvant chemotherapy. (See related story.)
The FDA’s decision was based on data from the Destiny-Breast04 phase three trial in which Enhertu demonstrated improvement in progression-free and overall survival in patients with HER2-low unresectable and/or metastatic breast cancer with hormone-receptor–positive or HR-negative disease versus physician’s choice of chemotherapy.
Ken Takeshita, MD, Daiichi’s global head of R&D, said in a statement, “Destiny-Breast04, in which Enhertu showed a clinically meaningful survival benefit in patients with HER2-low metastatic breast cancer, is the first trial to demonstrate that selecting patients for treatment based on low expression of HER2 has the potential to change the diagnostic and treatment paradigms for these patients.”
In May, the drug was approved for patients with unresectable or metastatic HER2-positive breast cancer treated with a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and who have developed recurrence during or within six months of completing therapy. This approval was based on results of the Destiny-Breast03 phase three trial.
BioFire Joint Infection Panel has de novo authorization
BioMérieux’s BioFire Joint Infection Panel received de novo authorization from the Food and Drug Administration. The panel tests for 31 pathogens implicated in most acute joint infections and includes eight antimicrobial resistance genes.
It provides results using synovial fluid samples obtained directly from the affected joint. It runs on the FilmArray 2.0 and Torch systems with two minutes of sample preparation time.
BioMérieux is planning for a commercial launch in the U.S. by July.
FDA approves Aptima CMV Quant assay
The Food and Drug Administration approved Hologic’s Aptima CMV Quant assay to quantify the viral load of cytomegalovirus in patients who have had solid organ or stem cell transplants. The test is the first to be introduced in the U.S. by Hologic for post-transplant pathogen detection and monitoring on its Panther system.
The assay also is CE marked for diagnostic and viral load monitoring use in Europe. Hologic intends to pursue regulatory approvals for other transplant assays in development, including BK virus and Epstein-Barr virus.
FDA authorizes IVD test for patients evaluated for AD
The Food and Drug Administration granted de novo marketing authorization for Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test for assessing β-amyloid pathology in patients evaluated for Alzheimer’s disease and other causes of cognitive decline. The test, to which the FDA had granted breakthrough device designation, is the first FDA-authorized in vitro diagnostic test in the U.S. to aid in assessing Alzheimer’s disease and other causes of cognitive decline.
The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is a minimally invasive and accessible measure of β-amyloid that can detect the formation of amyloid plaques early in the disease. It measures the concentrations of β-amyloid 1-42 and β-amyloid 1-40 in the CSF to calculate a numerical ratio as a proxy for the presence of β-amyloid plaque in the brain.
William Hu, MD, PhD, chief of the Division of Cognitive Neurology at Robert Wood Johnson Medical School and principal investigator of the Hu Lab, which focuses on researching fluid biomarkers for AD and other neurodegenerative disorders, called the FDA’s authorization “a significant advance that marks the advent of a new era, facilitating more efficient clinical trials for new AD therapies and enabling patients and their doctors to make more informed decisions and take action much earlier in the disease process.”
The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is not intended as a screening or standalone assay to diagnose AD.