Pfizer's Xalkori wins breakthrough status
The U.S. Food and Drug Administration has designated Pfizer Inc.'s lung cancer treatment Xalkori as a breakthrough therapy, the company announced Tuesday.
Xalkori, discovered at Pfizer's laboratories in LaJolla, Calif., and developed largely in Groton, was shown to be a substantial improvement over other therapies in a small cell lung cancer subgroup known as ROS1-positive. This represents only about 1 percent of such lung cancer cases, according to Pfizer.
Breakthrough designation, in effect for only the past three years, helps firms quicken the pace of regulatory review for potentially life-saving medicines that have indicated a potential to be substantially better than existing therapies.
"We are excited that the FDA has granted breakthrough therapy designation for Xalkori," Mace Rothenberg, chief medical officer for Pfizer Oncology, said in a statement. "Xalkori ... can potentially make a real difference for patients."
In 2013, Pfizer won final approval from the FDA for administering Xalkori to patients with advanced lung cancer who had another genetic abnormality known as ALK-positive.
The most recent breakthrough designation followed analysis of an early-stage trial of Xalkori on 50 patients. According to Pfizer, the study showed Xalkori was effective in fighting tumors and was safe to use.
Pfizer said lung tumors are the leading cause of cancer deaths worldwide. Often caught too late, lung cancer is a disease in which only 5 percent of patients with advanced cases will survive more than five years, the company said.
l.howard@theday.com
Twitter: @KingstonLeeHow
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