Breakthrough Status May Spur J&J Drug to Market Early
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Johnson & Johnson and Pharmacyclics Inc. may push their experimental cancer drug to market two years faster than projected after gaining a new status the government now grants promising therapies.
Pharmacyclics sent an application for review for ibrutinib to the Food and Drug Administration on July 10 to treat two blood cancers, which the agency may decide on by March 10. This is two years ahead of schedule after the FDA in February named ibrutinib a breakthrough therapy, said Jay Siegel, J&J’s head of global regulatory affairs. Such a designation prioritizes a drug’s development among agency staff.