Pfizer's new drug Xalkori has received FDA approval to treat ALK-positive non-small-cell lung cancer, reports Scott Hensley at the NPR Shots blog. The twice-a-day pill can only be prescribed to the few thousand people each year who develop ALK-positive lung cancer, quite a contrast from the blockbuster drugs taken by millions of patients that Pfizer is known for developing, Hensley says. Only about 3 percent to 5 percent of non-small-cell lung cancer patients test positive for ALK each year — about 6,500 to 11,000 people in the US. FDA approved the drug in combination with a companion diagnostic to detect the ALK variation. "The new, highly targeted cancer pill won't come cheap at about $9,600 a month. But the benefits for those with the ALK-positive cancers appear to be substantial. Half or more of patients in the studies cited in the FDA approval responded well to treatment with Xalkori. Their tumors shrank or disappeared," Hensley says. Xalkori was approved under and FDA priority review program reserved for drugs with "special promise," Hensley adds. It's still unknown whether the drug extends life, but Pfizer will continue to do research to confirm FDA's assessment of the drug.
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