Maintenance. We are currently updating the site. Please check back shortly
Members login
  • TrustLaw
  • Members Portal
Subscribe Donate

U.S. FDA approves J&J, Pharmacyclics lymphoma drug

Source: Reuters - Wed, 13 Nov 2013 18:43 GMT
Author: Reuters
hum-dis
Tweet Recommend Google + LinkedIn Email Print
Leave us a comment

By Bill Berkrot

Nov 13 (Reuters) - U.S. health regulators on Wednesday approved a drug to treat a rare and aggressive form of non-Hodgkin lymphoma developed by Johnson & Johnson and Pharmacyclics Inc, becoming the second drug that had received the FDA's new breakthrough therapy designation to gain approval.

The drug, to be sold under the brand name Imbruvica, and known chemically as ibrutinib, was approved to treat mantle cell lymphoma in patients who have received prior treatment with at least one other medicine, such as Celgene Corp's Revlimid. It works by inhibiting an enzyme needed by the cancer to multiply and spread.

Mantle cell lymphoma, which represents about 6 percent of non-Hodgkin lymphoma cases in the United States, has typically spread to lymph nodes, bone marrow and other organs by the time it is diagnosed, the Food and Drug Administration said.

The FDA earlier this month approved Roche's Gazyva to treat chronic lymphocytic leukemia (CLL), another type of blood cancer, making it the first drug approved after receiving the breakthrough designation.

The FDA gives a breakthrough designation when it believes a medicine may offer a substantial improvement over existing therapies for serious or life-threatening diseases.

"The agency worked cooperatively with the companies to expedite the drug's development, review and approval, reflecting the promise of the breakthrough therapy designation program," Richard Pazdur, director of the FDA's Office of Hematology and Oncology Products, said in a statement.

Imbruvica is also awaiting an approval decision to treat CLL, which some analysts believed would come at the same time as the U.S. lymphoma approval.

"This is a relative short-time disappointment versus Wall Street expectations for simultaneous approval in both indications with a broad label," RBC Capital Markets analyst Michael Yee said in a research note.

Yee, in an email, said RBC is forecasting long-term annual worldwide sales of $5 billion for Imbruvica.

Pharmacyclics shares were up $3.20, or 2.6 percent, at $122.87 on Nasdaq. Shares of Johnson & Johnson were down 85 cents, or 0.9 percent ,at $92.71 on the New York Stock Exchange.

We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of the Thomson Reuters Foundation. For more information see our Acceptable Use Policy.

comments powered by Disqus