The FDA has stamped an approval on Pfizer's ($PFE) new kidney cancer drug axitinib, which the drug giant plans to market as Inlyta. And the approval marks another win on the targeted cancer drug front for Pfizer, which last year nabbed an FDA OK for its non-small cell lung cancer treatment Xalkori for a subset of patients whose tumors express ALK mutations.
The approval for Inlyta, a selective VEGF inhibitor, comes after Pfizer showed in a 723-patient trial that the drug could provide 6.7 months of median progression-free survival, topping the 4.7 months among patients who took Onyx Pharmaceuticals' ($ONXX) Nexavar (sorafenib).
Pfizer has a new horse in what is becoming a crowded race in the market for advanced kidney cancer drugs. According to the FDA, there have now been 7 drugs for kidney cancer approved in the U.S. since the agency's nod for sorafenib in 2005. Pfizer also markets two other drugs for advanced kidney cancer, Sutent and Torisel.
Aveo Pharmaceuticals ($AVEO) plans to seek an approval for its own VEGF inhibitor against kidney cancer, tivozanib. Both Pfizer's and Aveo's horses in this race target multiple VEGF receptors. The FDA is letting Pfizer market its drug for treating patients who have already failed one prior systemic therapy, according to Pfizer's release. Cambridge, MA-based Aveo has ambitious plans to win an FDA approval for tivozanib as a first-line therapy for advanced renal cell carcinoma.
Despite the competition in this market, the FDA nod supports Pfizer CEO Ian Read's plan to focus the drugmaker's R&D efforts on targeted medicines that serve the needs of specific patients and, of course, adds another commercial product to the company's roster as it battles to replace revenue lost to generic drugs.
- here's the FDA release
Pfizer (finally) wins a big one with crizotinib approval for lung cancer
UPDATED: Aveo shares sink on weak PhIII face-off with Nexavar