FDA approves Gadavist for breast cancer evaluation

Evan Godt | | Health Imaging | Diagnostic Imaging

The FDA has approved Bayer HealthCare’s Gadavist (gadobutrol) as the first intravenous MR contrast agent for evaluation of breast cancer in the U.S.

The approval is based on a priority review of a pair of Phase 3 trials, GEMMA-1 and GEMMA-2. Combined, the studies looked at 787 patients recently diagnosed with breast cancer from 13 countries and found Gadavist-enhanced breast MRI improved the ability of readers to assess the presence of breast cancer. Sensitivity for Gadavist-enhanced breast MRI in detecting malignant disease ranged from 80 to 89 percent, while sensitivity for unenhanced MRI ranged from 37 to 73 percent. Specificity of greater than 80 percent was reported for Gadavist-enhanced breast MRIs by five of the six readers involved in the studies.

The studies also indicated that in breasts with malignancy, Gadavist-enhanced breast MRI overestimated the histologically confirmed extent of malignancy in up to half of patients.  

Evan Godt
Evan Godt, Writer

Evan joined TriMed in 2011, writing primarily for Health Imaging. Prior to diving into medical journalism, Evan worked for the Nine Network of Public Media in St. Louis. He also has worked in public relations and education. Evan studied journalism at the University of Missouri, with an emphasis on broadcast media.

Related Content

AI rules out abnormal findings on chest X-rays, significantly reducing workloads
Older adults among the walking wounded with incident TBI
Philips moves digital pathology to the cloud with AWS
PHOTO GALLERY: What does fetal medical imaging look like?
Speaker laments radiology’s major contribution to climate change
Radiologist accuracy takes a hit overnight, especially with advanced imaging exams

Around the web

Cardiovascular Business
Positron partners with Upbeat Cardiology Solutions to improve cardiac PET/CT access

Positron, a New York-based nuclear imaging company, will now provide Upbeat Cardiology Solutions with advanced PET/CT systems and services. 

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.