Home / Health / FDA Greenlights New Cancer Drugs, MRI Agents
FDA Greenlights New Cancer Drugs, MRI Agents
15 Jun
Summary
- Bayer's Ambelvist MRI contrast agent approved for various patient groups.
- AstraZeneca's Truqap approved for specific prostate cancer cases.
- Roche's PTEN CDx becomes first companion diagnostic of its kind approved.
The U.S. Food and Drug Administration (FDA) has recently authorized several critical medical products, offering new therapeutic and diagnostic options. Bayer's Ambelvist, a low-dose MRI contrast agent, is now approved for detecting tissue with atypical vascularity across adult, pediatric, and neonatal populations. This agent aids in monitoring diseases of the central nervous system and other conditions.
AstraZeneca's Truqap (capivasertib) has gained FDA approval when used with androgen deprivation therapy (ADT) and Zytiga for specific prostate cancer patients. This combination demonstrated a significant reduction in the risk of disease progression or death in clinical trials.
Complementing this, Roche's VENTANA PTEN (SP218) RxDx qualitative diagnostic assay is the first companion diagnostic approved by the FDA for identifying PTEN-deficient prostate cancers. This approval directly supports the use of Truqap by ensuring patient eligibility for this targeted therapy.
Further advancements include MSD's approval of Keytruda in combination with Welireg for post-surgical renal cell carcinoma. These recent approvals highlight a period of significant progress in oncology and medical imaging.
