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FDA Grants Pfizer Approval of Sutent (sunitinib malate) as Adjuvant Treatment in Adults with High Risk of Recurrent RCC Following Nephrectomy.

M2 PHARMA-November 20, 2017-FDA Grants Pfizer Approval of Sutent (sunitinib malate) as Adjuvant Treatment in Adults with High Risk of Recurrent RCC Following Nephrectomy


- The US Food and Drug Administration has approved a new indication expanding the use of New York, New York-based biopharmaceutical and healthcare products specialist Pfizer Inc.'s (NYSE: PFE) Sutent (sunitinib malate), to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy, the company said.

The approval was based on results from the S-TRAC trial, a multicenter, international, randomized, double-blind, placebo-controlled Phase 3 trial of Sutent versus placebo in 615 patients with clear cell histology and high risk of recurrent RCC following nephrectomy.

The study met its primary endpoint of improving disease-free survival (DFS), defined as the interval between randomization and tumor recurrence, or secondary primary cancer or death from any cause.

Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases, some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer.

Sunitinib was evaluated for its inhibitory activity against a variety of kinases (>80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFR? and PDGFR?), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor, Fms-like tyrosine kinase-3, colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor.

Now approved in 119 countries across diagnoses, more than 350,000 patients worldwide have been treated with Sutent.

Pfizer discovers, develops, manufactures, and sells healthcare products worldwide. Its global portfolio includes medicines and vaccines as well as consumer health care products. The company collaborates with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world.

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Publication:M2 Pharma
Date:Nov 20, 2017
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