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

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FDA grants fourth breakthrough designation to Imbruvica

YOU MAY BE INTERESTED IN

In the Headlines: Missing record of NCAB meetings restored to NIH website

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woesDirectors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheavalSusan Collins: Trump’s 40% cut is “so disturbing”

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosisObservational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms

Insights from ASCO 2025: Real-world evidence drives clinical decision-making

Never miss an issue!

Login

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woes
Directors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheaval
Susan Collins: Trump’s 40% cut is “so disturbing”

In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times
“In the NCI director’s office, we have a photograph of a stone bridge, and it asks the question, which stone holds up the bridge? And the answer is all of them.”

CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosis
Observational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms