logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Has Granted Priority Review To NDA For Regorafenib, Reveals Onyx Pharma

Onyx Pharmaceuticals Inc (ONXX), a global biopharmaceutical company, and Bayer Healthcare Pharmaceuticals Inc, have, on Thursday, jointly announced that the U.S Food and Drug Administration or the FDA, has granted priority review designation to the New Drug Application, or the NDA, for the oral multi-kinase inhibitor regorafenib.

The company further stated that Bayer Healthcare had filed the NDA at the end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose disease has progressed after approved standard therapies.

The company stated that Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

Onyx Pharmaceuticals further added that the FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Furthermore, the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Low-cost airline Allegiant Air announced its order for brand-new aircraft for the first time in its history. The carrier announced on Friday it had reached a deal to purchase 12 current-generation models of Airbus' A320 narrow-body jets. The company termed the deal as "another step towards Allegiant's... Los Angeles City officials have filed criminal charges against Soylent CEO Robert Rhinehart for placing a bright red shipping container on Montecito Heights hillside as part of his "experiment in sustainable living." City Attorney Mike Feuer Friday announced that his office has filed multiple criminal... A new study says that if Hillary Clinton is elected then her proposals will strengthen the U.S. economy and create millions of jobs. According to Moody's Analytics, Hillary Clinton's economic proposal would oversee a "somewhat stronger U.S. economy." The conclusion was reached after assessing her...
comments powered by Disqus
Follow RTT