The HealthCare unit of Bayer (BAYRY - Free Report) recently announced that the US Food and Drug Administration (FDA) has cleared its oncology candidate, Stivarga (regorafenib). The FDA approved Stivarga, an oral multi-kinase inhibitor, for use in treatment-experienced metastatic colorectal cancer patients.
We note that the FDA reviewed the new drug application (NDA), submitted in April 2012, for Stivarga on a priority basis. 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. Priority review status means that the FDA will review the marketing application within six months instead of the standard ten months.
The approval came in on the basis of encouraging data from a pivotal phase III study (CORRECT: n=760), which evaluated Stivarga in metastatic colorectal cancer patients, whose disease had progressed even after treatment with the standard drugs prescribed for the disease. Statistically significant improvement in overall survival (OS) and progression free survival (PFS) were observed in the Stivarga arm compared to placebo.
Stivarga is being reviewed on a priority basis in Japan for treating patients suffering from metastatic colorectal cancer, whose disease has progressed despite prior treatment. Bayer is also seeking European approval for the candidate for the indication.
Bayer is also looking to get Stivarga approved for treating patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The company is seeking approval on the basis of encouraging data from a phase III study (GRID: n=199), which evaluated patients suffering from metastatic and/or unresectable gastrointestinal stromal tumors. The disease had progressed in the evaluated patients in spite of being previously treated with Novartis’ (NVS - Free Report) Gleevec and Pfizer’s (PFE - Free Report) Sutent. The data was presented at the June 2012 annual conference of the American Society of Clinical Oncology (ASCO).
Bayer and Onyx Pharmaceuticals, Inc. , as per an agreement inked last year, will co-promote Stivarga in the US. Onyx will receive royalties on net sales of Stivarga.
We remind investors that last month Sanofi’s (SNY - Free Report) colorectal cancer drug, Zaltrap, received approval. The FDA approved Zaltrap as a combination therapy for treating patients suffering from metastatic colorectal cancer who are either resistant to or whose disease has progressed following treatment with an oxaliplatin-containing regimen.
We have an Outperform recommendation on Bayer. The stock carries a Zacks #1 Rank (Strong Buy rating) in the short run.