Pharmacyclics Drug Wins One Approval, Awaits Another
The Food and Drug Administration approved Pharmacyclics’ (PCYC) cancer drug ibrutinib Wednesday, but it only cleared one of the two diseases the company had applied to treat. The FDA approved the drug, now renamed Imbruvica, to treat mantle-cell lymphoma, a rare form of lymphoma currently treated with Celgene’s (CELG) Revlimid and Takeda’s Velcade. It’s only the second product to be approved under the agency’s new “breakthrough therapy”