AbbVie, J&J’s Imbruvica Gets Breakthrough Therapy Status

Imbruvica got a fourth Breakthrough Therapy Designation (BTD), this time for a non-cancer indication. The FDA granted BTD to Imbruvica for the treatment of chronic graft-versus-host-disease (cGVHD) after one or more lines of systemic therapy have failed. Imbruvica was also granted Orphan Drug Designation (ODD) for the indication.

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Breakthrough Therapy Designation helps fasten the development and review of drugs which are being evaluated for the treatment of serious conditions and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments on clinically significant endpoint(s).