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12:00 AM
 | 
Jun 15, 2009
 |  BioCentury  |  Product Development

Arguing for a Third Way

With two oral multi-kinase inhibitors ahead of it in the market, GlaxoSmithKline plc hopes to position its pazopanib as the agent of choice for front-line treatment of renal cell carcinoma based on a better safety and tolerability profile.

Sutent sunitinib, a small molecule inhibitor of multiple tyrosine kinase receptors from Pfizer Inc., has been widely adopted as the front-line therapy of choice in the U.S. and Europe since its approval in early 2006, according to Debasish Roychowdhury, SVP and head of medicines development in GSK's oncology division. Nexavar sorafenib, a multi-kinase inhibitor from Bayer AG and Onyx Pharmaceuticals Inc., also is approved for advanced RCC.

Sutent's label includes Phase III data in treatment-naïve patients, while Nexavar's includes only Phase II data in that population.

According to Sutent's label, treatment-naïve RCC patients receiving the single agent demonstrated progression-free survival of 47.3 weeks compared with 22 weeks for those receiving interferon alpha, with a hazard ratio of 0.415.

Treatment-naïve patients receiving Nexavar in a Phase II trial had PFS of 23.3 weeks compared to 5.9 weeks for placebo, according to its label. In a...

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