Pharmacyclics Up on Imbruvica Label Expansion in the U.S.

Pharmacyclics Inc. (PCYC) announced a label expansion for its drug Imbruvica in the U.S. Imbruvica gained FDA approval for all lines of therapy for the treatment of patients suffering from Waldenstrom's macroglobulinemia (WM).

This makes Imbruvica the first and only FDA approved treatment for this indication. Approval came more than two months ahead of schedule. Pharmacyclics’ shares were up 1.3% following the news.

We remind investors that the FDA was expected to render a final decision on the company’s supplemental New Drug Application for Imbruvica by Apr 17, 2015. We note that the FDA had granted Breakthrough Therapy designation to Imbruvica for this indication in Feb 2013.

The FDA cleared Imbruvica for the WM indication primarily on the basis of encouraging data from a phase II study in which 63 patients demonstrated a response rate of 62%.

We note that this is the fourth approval for Imbruvica. Imbruvica is currently approved for the treatment of patients with mantle cell lymphoma or chronic lymphocytic leukemia (CLL) who have received at least one previous therapy and for CLL patients with a deletion of the short arm of chromosome 17.

We are encouraged by the label expansion of Imbruvica. As per the American Cancer Society, nearly 1,000 to 1,500 new cases of WM are reported each year in the U.S.

Imbruvica is Pharmacyclics’ sole marketed product. As per preliminary results announced earlier this month, the company expects U.S. net product revenue for Imbruvica to be approximately $492 million for 2014. For 2015, the company expects Imbruvica U.S. net product revenue to be approximately $1 billion, representing a year-over-year jump of 103%.

We remind investors that Pharmacyclics has an agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, for Imbruvica.

Meanwhile, Pharmacyclics is working on expanding Imbruvica’s label further and is evaluating the drug for indications like small lymphocytic lymphoma and diffuse large B-cell lymphoma among others.

Pharmacyclics currently carries a Zacks Rank #2 (Buy). Some better-ranked stocks in the health care sector include Biodel Inc. (BIOD) and Lannett Company, Inc. (LCI). Both carry a Zacks Rank #1 (Strong Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

To read this article on Zacks.com click here.

Zacks Investment Research