INDIANAPOLIS
A potential treatment for advanced lung cancer from Pfizer Inc. has about an 80 percent chance of receiving Food and Drug Administration approval this year, according to a Credit Suisse analyst.
The world's largest drugmaker presented research earlier this month on crizotinib that shows the treatment appears to double survival over standard drugs against tumors with a certain genetic mutation. The FDA gave the drug a "Fast Track designation" last December, and the New York drugmaker was able to start submitting batches of data in January, instead of waiting until all studies are completed.
Two larger, late-stage studies comparing crizotinib directly to standard treatments are continuing, one in patients for whom prior drugs didn't work and one in new patients. There are no treatments specifically for patients with this type of lung cancer, although some others are in much earlier stages of testing.
THE OPINION: Analyst Catherine Arnold said in a Wednesday research note the drug was a solid clinical candidate for accelerated FDA approval in the fourth quarter. The analyst increased the probability of regulatory success from 65 percent after reviewing clinical data.
Arnold said sales for crizotinib could top $1 billion in 2015 and peak at about $1.5 billion by 2020, and there will be no new competition for that type of therapy for at least three years.
THE STOCK: Up 5 cents to $20.24 in late morning trading, while broader trading indexes climbed less than 1 percent.