Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

Pharmacyclics, Inc. (PCYC), Johnson & Johnson (JNJ): The FDA Loves This Drug

It should come as no surprise to anyone that the Food and Drug Administration granted a priority review for Pharmacyclics, Inc. (NASDAQ:PCYC) and Johnson & Johnson (NYSE:JNJ)‘s blood cancer drug ibrutinib.

The agency is clearly in love with the drug. It’s already granted a Breakthrough Therapy Designation to the drug for many different indications.

The priority review shaves four months off the standard review time, and the Breakthrough Designation should speed up the process even more. I doubt the FDA will take the full six months it’s allotted under the priority review. An approval by the end of the year seems highly likely.

Pharmacyclics, Inc. (NASDAQ:PCYC)

Of course, the FDA’s Office of Hematology and Oncology Products was handing down decisions well ahead of its internal deadlines before the Breakthrough Designation came about, so it isn’t clear exactly how much the new designation will help speed the process. Clearly if the agency thinks the drug is important, it’ll put more personnel on the review.

While it might not help the company all that much, the designation does give investors an idea of what the agency thinks of the early data. Unlike the old fast-track designation, there seems to be some discrimination in what drugs get the indication. The division that reviews ibrutinib has granted 44% of the Breakthrough Therapy requests it’s acted on.

The new drug application covers treating two B-cell malignancy indications: previously treated mantle cell lymphoma and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma. The data for that population has been outstanding with overall response rate of 68%, which is especially promising since the patients have already failed Celgene Corporation (NASDAQ:CELG)‘s Revlimid or Takeda‘s Velcade.

The efficacy should give investors confidence that ibrutinib could compete directly with Revlimid and Velcade, although most doctors won’t prescribe it as a first-line treatment until Pharmacyclics, Inc. (NASDAQ:PCYC) and Johnson & Johnson (NYSE:JNJ) run a head-to-head trial. The companies are also testing ibrutinib in a couple of other blood cancers.

The FDA’s acceptance of the filing triggers a $75 million payment from Johnson & Johnson (NYSE:JNJ) to Pharmacyclics, Inc. (NASDAQ:PCYC), which should help the biotech pay for the clinical trials. In addition to ibrutinib, Pharmacyclics, Inc. (NASDAQ:PCYC) has three other drugs in development.

The article The FDA Loves This Drug originally appeared on and is written by Brian Orelli.

Fool contributor Brian Orelli has no position in any stocks mentioned. The Motley Fool recommends Celgene and Johnson & Johnson. The Motley Fool owns shares of Johnson & Johnson.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

Biotech Stock Alert - 20% Guaranteed Return in One Year

Hedge Funds and Insiders Are Piling Into

One of 2015's best hedge funds and two insiders snapped up shares of this medical device stock recently. We believe its transformative and disruptive device will storm the $3+ billion market and help it achieve 500%-1000% gains in 3 years.

Get your FREE REPORT and the details of our 20% return guarantee today.

Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.
Loading Comments...

Thanks! An email with instructions is sent to !

Your email already exists in our database. Click here to go to your subscriptions

Insider Monkey returned 102% in 3 years!! Wondering How?

Download a complete edition of our newsletter for free!