Pharmacyclics, J&J file for cancer drug approval

Pharmacyclics and Johnson & Johnson submit blood cancer drug ibrutinib to FDA for approval

Associated Press

NEW YORK (AP) -- Pharmacyclics Inc. and Johnson & Johnson said Wednesday they filed for marketing approval of their blood cancer drug ibrutinib.

Pharmacyclics and J&J's Janssen unit are asking the Food and Drug Administration to approve ibrutinib as a treatment for mantle cell lymphoma and chronic lymphocytic leukemia. They are seeking a priority review, which would shorten the FDA's review period to six months from 10.

Ibrutinib would be Pharmacyclics' first approved drug, and the companies plan to market the drug together.

Shares of Pharmacyclics gained $11.26, or 12.6 percent, to $100.78 in morning trading, an all-time high.

Johnson & Johnson shares added 12 cents to $89.

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.

The FDA created the breakthrough therapy program in 2012 as a way to speed up the approval process for drugs that could be significant improvements in the treatment of serious or life-threatening diseases from what's currently on the market.

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