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

Reuters

By Bill Berkrot

Nov 13 (Reuters) - U.S. health regulators on Wednesdayapproved a drug to treat a rare and aggressive form ofnon-Hodgkin lymphoma developed by Johnson & Johnson andPharmacyclics Inc, becoming the second drug that hadreceived the FDA's new breakthrough therapy designation to gainapproval.

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

Mantle cell lymphoma, which represents about 6 percent ofnon-Hodgkin lymphoma cases in the United States, has typicallyspread to lymph nodes, bone marrow and other organs by the timeit is diagnosed, the Food and Drug Administration said.

The FDA earlier this month approved Roche's Gazyvato treat chronic lymphocytic leukemia (CLL), another type ofblood cancer, making it the first drug approved after receivingthe breakthrough designation.

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

"The agency worked cooperatively with the companies toexpedite the drug's development, review and approval, reflectingthe promise of the breakthrough therapy designation program,"Richard Pazdur, director of the FDA's Office of Hematology andOncology 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 asthe U.S. lymphoma approval.

"This is a relative short-time disappointment versus WallStreet expectations for simultaneous approval in bothindications with a broad label," RBC Capital Markets analystMichael Yee said in a research note.

Yee, in an email, said RBC is forecasting long-term annualworldwide 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 85cents, or 0.9 percent ,at $92.71 on the New York Stock Exchange.

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