Pfizer Inc., has entered an agreement with drug developer SFJ Pharma Ltd. II to conduct a late-stage trial in Asia of Pfizer's potential kidney cancer treatment axitinib.
The study will focus on patients at high risk of recurrent renal cell carcinoma following a nephrectomy, or removal of the kidneys.
Pfizer, based in New York, is seeking Food and Drug Administration approval to market the drug for advanced renal cell carcinoma, the most common type of kidney cancer. Last month, a panel of FDA advisors voted unanimously that the benefits of the drug outweigh its risks.
The FDA is not required to approve drugs backed by its expert panels, though it often does. It is expected to make a final decision on whether to approve the drug in the first quarter.
Axitinib also is under regulatory review in Europe and Japan.
SFJ Pharma will provide funding and clinical development supervision for the late-stage trial in Asia and will be eligible to receive milestone payments under the deal.
It is part of the SFJ Pharmaceuticals Group, a drug development company formed in 2009 and backed by the venture capital firms Abingworth, Clarus and Fintech. SFJ Pharma Pharmaceuticals is based in Pleasanton, California.