Pharmaprojects R&D Pipeline News Feed
Dual filing for GlaxoSmithKline's pazopanib
13 Mar 2009
GlaxoSmithKline's angiogenesis inhibitor, Armala (pazopanib), has been filed for approval in the the EU and the US for the treatment of renal cell carcinoma (RCC). Pazopanib is a multiple tyrosine kinase receptor inhibitor, targeting VEGF, PDGFR and c-kit.
The EU and US filings follow positive data from a randomized, placebo-controlled Phase III trial in 435 patients with advanced or metastatic RCC, in which pazopanib met its primary endpoint of progression-free survival. A non-randomized extension study in 132 RCC patients is also underway.
Speaking of the filings, GlaxoSmithKline's chairman of R&D, Dr Moncef Slaoui said that pazopanib would be "a significant, if not the gold standard, VEGF inhibitor" due to its improved efficacy and safety/tolerability profile compared with other VEGF inhibitors.
The filings bring pazopanib one step closer to challenging Pfizer's Sutent (sunitinib), which is the current standard-of-care for RCC. GlaxoSmithKline now plans to establish pazopanib in this indication by showing benefit in an ongoing Phase III trial versus Sutent in newly-diagnosed RCC patients. Pazopanib was granted EU orphan drug status for RCC in 2006.
