UPDATE 1-U.S. FDA approves J&J, Pharmacyclics lymphoma drug

Wed Nov 13, 2013 1:43pm EST

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.

A couple walks along the rough surf during sunset at Oahu's North Shore, December 26, 2013. REUTERS/Kevin Lamarque

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