Pfizer Inc. announced that the FDA and the European Medicines Agency (EMA) accepted the company’s regulatory submission for label expansion of its renal cell carcinoma (RCC) drug, Sutent (sunitinib). The FDA’s response is expected in January 2018.
The EMA validated the new indication request as a type II variation application for Sutent in the same patient population using it now. Sutent is already approved for advanced RCC, imatinib-resistant or intolerant gastrointestinal stromal tumors, and advanced pancreatic neuroendocrine tumors. The EMA validation is the initiation of the EMA’s centralized review process.
The company is looking to expand Sutent’s label for adjuvant treatment of adult patients at high risk of recurrent RCC after surgery. There are no approved therapies for patients with kidney cancer after surgery, Zacks.com wrote.
The regulatory submissions are supported by positive results from a Phase 3 S-TRAC, (Sunitinib Trial in Adjuvant Renal Cancer) study. The S-TRAC trial comprised two cohorts: Global and China. The most recent results are from the Global cohort.
A rare form of renal cancer now has a drug treatment in Phase 2 study. In May 2017, Peloton Therapeutics (Dallas, TX) announced that patient dosing had begun in a Phase 2 study of treatment for patients with von Hippel-Lindau (VHL) disease–associated kidney cancer.
VHL is a hereditary form of cancer caused by the mutation in or deletion of the VHL gene, which can cause blood vessel cells in particular to grow, resulting in the tumors. These tumors can appear in up to 10 different areas of the body, including the kidneys, brain, and spine.
The orally administered drug, PT2385, targets hypoxia-inducible factor 2a, Peloton said in a statement. The study will evaluate the overall response rate of VHL disease–associated clear cell renal cell carcinoma (ccRCC) tumors in VHL patients.
