publication date: Dec 3, 2013
FDA granted an accelerated approval to Imbruvica (ibrutinib) for mantle cell lymphoma patients who have received at least one prior therapy.
Imbruvica was approved four months after submission of its New Drug Application. The agent is sponsored by Pharmacyclics Inc.
The drug received the Breakthrough Therapy designation due to the overall response rate and duration of response seen in the phase II study, PCYC-1104, and the serious and life-threatening nature of MCL.
With approval, it becomes the second Breakthrough Therapy to get on the market.
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