The FDA’s Oncologic Drugs Advisory Committee voted 13-0 that Pfizer’s drug axitinib (Inlyta) had a favorable benefit-risk profile for patients with advanced renal cell carcinoma after initial treatment has failed. The FDA is due to make a final decision in the first half of 2012.
Panelists said the oral drug was at least as safe and effective as previously approved treatments, such as sorafenib (Nexavar). It also had different side effects than other drugs for the disease, which could be important for patients who cannot tolerate older treatments, said Wyndham Wilson, MD, Chair of the panel and Chief of the Lymphoma Therapeutics Section at NCI.
“It’s my take that the toxicity profile is different, there’s benefit there, and it’s not inferior to currently approved [tyrosine kinase inhibitors],” Dr. Wilson said. “If you have two drugs that are equivalently effective, ... different toxicity profiles can be very useful for the individual.”
Overall, in Pfizer’s clinical trial, axitinib slowed down the progression of cancer by 2 months compared to sorafenib for patients who had already been treated for advanced kidney cancer. But the findings differed depending on which drug patients took beforehand. For those who initially took sunitinib (Sutent), axitinib slowed the disease by only 1.4 months, vs 5.6 months in patients previously treated with cytokines. ■