Pfizer's ($PFE) cancer drug team nailed a unanimous endorsement from an FDA expert panel this morning following its review of axitinib, setting it on a path to a likely approval for patients with advanced kidney cancer. The experts formally concluded that the drug's benefits justified the risks it posed to patients.
That winning vote represents a small but important step for Pfizer, which stands to earn more than a half billion dollars a year from the drug if it goes on to an approval. While not a blockbuster, the drug represents at least a partial response to the loss of the Lipitor franchise. In recent years Pfizer had earned a reputation as the poster child for clinical stage failures, suffering through a series of embarrassing setbacks. But recently it's shown signs of becoming more effective at developing new drugs. Pfizer plans to sell axitinib as Inlyta.
Some of the experts who voted in favor of the drug noted that axitinib compared favorably with Nexavar. But with data supporting only two months of added progression-free survival, not all the experts were impressed. The Wall Street Journal noted that one of the panelists observed that the drug is "not a touchdown, and maybe not even a first down," but warranted approval.
Analysts have also been paying close attention to AVEO's rival kidney cancer drug, tivozanib, one of the most promising cancer drugs now in late-stage studies.
Pfizer seeking European approval on one of its top cancer prospects
Pfizer, GSK named in Onyx buyout gossip