US FDA approves sNDAs for Imbruvica and Azilect

USA-based Pharmacyclics (Nasdaq: PCYC) says that the US Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of Imbruvica (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval.

The sNDA was submitted to the FDA based on data from the randomized, multicenter, open label Phase III RESONATE trial, PCYC-1112-CA, a head-to-head comparison of Imbruvica versus ofatumumab in 391 patients with CLL or SLL who had received at least one prior therapy (The Pharma Letter April 8). The target date as defined by the Prescription Drug User Fee Act by which the FDA is planning to finalize the review of this application (PDUFA date) is October 7, 2014.

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