Bayer's AMBELVIST® (gadoquatrane) Receives FDA Approval as Lowest-Dose Macrocyclic Gadolinium-Based Contrast Agent for MRI
核心洞察
AMBELVIST (gadoquatrane) is now the lowest-dose macrocyclic gadolinium-based contrast agent approved in the U.S., with a recommended dose of 0.01 mmol/kg body weight.
The FDA approval is supported by Phase III QUANTI clinical studies demonstrating efficacy at a fraction of the gadolinium dose compared to conventional mGBCAs.
AMBELVIST delivers 60% less gadolinium compared to agents dosed at 0.1 mmol Gd/kg and 20% less compared to gadopiclenol at 0.05 mmol Gd/kg.
The U.S. Food and Drug Administration (FDA) has approved Bayer (搜索)'s AMBELVIST® (gadoquatrane), a next-generation intravenous macrocyclic gadolinium-based contrast agent (mGBCA) for contrast-enhanced magnetic resonance imaging (MRI). The agent is indicated to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates. With this approval, AMBELVIST becomes the lowest-dose mGBCA available in the United States.
AMBELVIST features a novel tetrameric structure and high relaxivity, a measure of signal enhancement. The recommended dose is 0.01 mmol/kg actual body weight, which delivers 0.04 mmol Gd/kg body weight. This represents 60% less gadolinium compared to mGBCAs with a gadolinium content of 0.1 mmol Gd/kg body weight and 20% less gadolinium compared to gadopiclenol, which has a Gd content of 0.05 mmol Gd/kg body weight.
Clinical Significance and Unmet Need
Contrast-enhanced MRI plays an important role in detecting abnormalities, monitoring disease progression, and informing treatment decisions. For adults and children with chronic diseases requiring close, long-term monitoring—such as multiple sclerosis (搜索), other neurological or spinal conditions, and various cancers—regular, serial imaging may be necessary. The availability of a lower-gadolinium-dose option addresses growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients.
"I often rely on contrast-enhanced MRI exams to inform clinical decision making," said Dr. Christopher Hancock, Director of Neuroradiology at HALO Diagnostics Desert Cities and an investigator for the QUANTI clinical studies. "With this approval, we now have an additional option that can help deliver contrast-enhanced images at the lowest macrocyclic GBCA dose, reducing gadolinium exposure while preserving the clinical information we often need."
Phase III QUANTI Clinical Trial Findings
The FDA approval is supported by data from the global pivotal Phase III QUANTI clinical studies, which evaluated the efficacy and safety of AMBELVIST in adult and pediatric patients, including term neonates, undergoing contrast-enhanced MRI. Key findings demonstrated increased lesion visualization with the combined pre-contrast and post-contrast MRI sets using the decreased gadolinium dose in AMBELVIST compared with pre-contrast MRI images alone.
In descriptive analyses, visualization scores and the number of lesions identified per blinded independent reader for AMBELVIST dosed at 0.01 mmol/kg body weight were similar to other tested mGBCAs with a gadolinium content of 0.1 mmol Gd/kg body weight.
The safety and effectiveness of AMBELVIST for use with MRI to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) have been established in pediatric patients, including term neonates. Use in this age group is supported by evidence from adequate and well-controlled studies in adults, with additional pharmacokinetic and safety data from 93 pediatric patients aged 28 days to less than 18 years who received one 0.01 mmol/kg dose of AMBELVIST and underwent MRI of any body region.
Safety Profile and Boxed Warning
AMBELVIST carries a Boxed Warning regarding risks associated with intrathecal administration and nephrogenic systemic fibrosis (搜索) (NSF). Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures; AMBELVIST is not approved for intrathecal use.
GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. The risk appears highest among patients with chronic, severe kidney disease (GFR less than 30 mL/min/1.73 m²) or acute kidney injury. The prescribing information recommends screening patients for acute kidney injury and other conditions that may reduce renal function, and estimating GFR through laboratory testing for patients at risk for chronically reduced renal function, such as those over age 60, with hypertension, or with diabetes.
AMBELVIST is contraindicated in patients with a history of severe hypersensitivity reactions to the agent. Additional warnings and precautions relate to hypersensitivity reactions, gadolinium retention, acute kidney injury, and interference with lesion visualization. The most frequently observed adverse reactions, occurring at an incidence of 0.2% or greater, were dizziness, headache, injection site reactions, nausea, vomiting, feeling hot, paresthesia, and pruritus.
Bayer (搜索)'s Radiology Legacy
Bayer (搜索) has played a pioneering role in MRI contrast agent development, having launched the first GBCA in 1988. AMBELVIST now joins its radiology portfolio as the lowest-dose mGBCA approved in the U.S.
"At Bayer, our focus has always been on enhancing patient care, and we are proud to introduce AMBELVIST as our next-generation option for contrast-enhanced MRI," said Jill Carbone, Vice President and Head of Radiology, North America Product & Pipeline, Bayer (搜索). "As a lower-gadolinium-dose GBCA, AMBELVIST supports healthcare providers in adhering to growing clinical guidance to utilize the lowest gadolinium dose necessary to adequately image patients."