Pfizer's Other Aggressive Play

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.

There's still time to get in on this gem
Give me five minutes and I'll show how you could own the best stock for 2014. Every year, The Motley Fool's chief investment officer hand-picks 1 stock with outstanding potential. But it's not just any run-of-the-mill company. It's a stock perfectly positioned to cash in on one of the upcoming year's most lucrative trends. Last year his pick skyrocketed 134%. And previous top picks have gained upwards of 908%, 1,252% and 1,303% over the subsequent years! Believe me, you don't want to miss what could be his biggest winner yet! Just click here to download your free copy of "The Motley Fool's Top Stock for 2014" today.


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2967140, ~/Articles/ArticleHandler.aspx, 11/28/2014 11:02:42 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement