FDA grants priority review to Pharmacyclics drug

Thu, 08/29/2013 - 7:54am
The Associated Press

Pharmacyclics is getting a priority review of its blood cancer treatment by federal regulators.

A priority review shortens a drug evaluation by the Food and Drug Administration from 10 months to six.

The acceptance of the application triggers a $75 million milestone payment to Pharmacyclics from Johnson & Johnson's Janssen unit.

The drug, Ibrutinib, would be Pharmacyclics' first on the market.

Pharmacyclics and Janssen are asking the FDA to approve ibrutinib as a treatment for previously treated cases of mantle cell lymphoma, an aggressive cancer that typically starts in lymph nodes; and chronic lymphocytic leukemia, a slow growing cancer of white blood cells that is the second-most common form of adult leukemia.

The companies say ibrutinib works by shutting down the major growth and survival pathway for cancerous B-cells.

The FDA has deemed the drug a potential breakthrough therapy as a treatment for mantle cell lymphoma, for chronic lymphocytic leukemia in patients with a genetic mutation, and for a type of non-Hodgkin lymphoma.

Shares of Pharmacyclics, based in Sunnyvale, Calif., closed at $111.70 on Wednesday and have climbed about 93 percent so far this year.


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