FDA Grants Priority Review To Pharmacyclics Cancer Drug
SUNNYVALE, Calif. (AP) — 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.