Last week, Pfizer (NYSE: PFE ) said that it plans to ask the Food and Drug Administration for accelerated approval for palbociclib as a first-line treatment for advanced breast cancer based on phase 2 data showing the drug extended progression-free survival by 10 months.
Palbociclib is in a new class of drugs that inhibits a pair of proteins called CDKs, which push cells through the cell cycle and cause cells to divide, creating a bigger tumor. CDKs tend to be overactive in tumor cells, and inhibiting them should block cell proliferation and therefore tumor growth.
Pfizer already has a phase 3 trial ongoing, but it won't complete until next year, so the accelerated approval could help get the drug on the market a year earlier. A speedy approval would help Pfizer get a foot in the doctor's door before other CDK inhibitors -- Novartis' (NYSE: NVS ) LEE011 and Eli Lilly's (NYSE: LLY ) bemaciclib -- hit the market. Novartis is shooting for applying for approval in 2016 and Eli Lilly is a little behind that.
In the video below, senior biotech specialist Brian Orelli and health-care analyst David Williamson discuss Pfizer's strategy and whether it will be able to beat Novartis and Eli Lilly to the market or if the FDA will ask to see phase 3 data on palbociclib before approving it. Investors will get a hint as to the FDA's thinking on Pfizer's strategy about 60 days after Pfizer files and when the FDA decides whether to accept the application.
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