FDA grants fourth breakthrough designation to Imbruvica

FDA granted a fourth Breakthrough Therapy Designation to Imbruvica (ibrutinib) as a potential treatment of chronic graft-versus-host-disease after failure of one or more lines of systemic therapy. The agency also granted the therapy Orphan Drug Designation for the condition.

The request was based on preliminary clinical data from a phase Ib/II study evaluating the safety and efficacy of Imbruvica for the treatment of patients with steroid-dependent or refractory cGVHD. Overall, Imbruvica has shown compelling preclinical data, a novel mechanism of action and promising early clinical efficacy data supporting an improvement in cGVHD based on the NIH consensus cGVHD Activity Assessment. Preliminary results from this trial were previously presented at the 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation in April and the 51st American Society of Clinical Oncology annual meeting in May 2015. Imbruvica is sponsored by AbbVie.

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FDA grants fourth breakthrough designation to Imbruvica

YOU MAY BE INTERESTED IN

Ellen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, Mary

Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director

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FDA to remove black box warnings on hormone therapy for menopauseTrump-era “gold standard science” is not to be confused with gold standard of scientific evidence

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Advancing symptom science at City of Hope and across the globe

Never miss an issue!

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FDA to remove black box warnings on hormone therapy for menopause
Trump-era “gold standard science” is not to be confused with gold standard of scientific evidence