Priority FDA Review for Stivarga - Analyst Blog
Recently, the HealthCare unit of
) announced that its oncology drug Stivarga (regorafenib) will be
reviewed on a priority basis by the US Food and Drug
Administration (FDA). Bayer is looking to get Stivarga, an oral
multi-kinase inhibitor, approved for treating patients suffering
from metastatic and/or unresectable gastrointestinal stromal
We note that the US regulatory authority generally reviews those drugs on a priority basis, which offer major advances in treating diseases that do not have adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months.
The new drug application (NDA), seeking approval of Stivarga for the GIST indication, was filed by Bayer in August 2012. The NDA was submitted on the basis of encouraging data from a phase III study (GRID: n=199), which evaluated patients suffering from metastatic and/or unresectable GIST. The disease had progressed in the evaluated patients in spite of being previously treated with Novartis ' ( NVS ) Gleevec and Pfizer 's ( PFE ) Sutent.
We remind investors that Stivarga was approved in the US in September 2012 for treating patients suffering from metastatic colorectal cancer (mCRC), whose disease had progressed even after treatment with the standard drugs prescribed for the disease. The approval was based on encouraging data from a pivotal phase III study (CORRECT: n=760). Bayer and Onyx Pharmaceuticals, Inc. ( ONXX ), as per an agreement inked last year, co-promote Stivarga in the US.
The sales potential of Stivarga would be further boosted if the FDA clears the drug for the GIST indication.
We have an Outperform recommendation on Bayer. The stock carries a Zacks #2 Rank (Buy rating) in the short run.
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