`pharmaphorum.com/news/abbvies-imbruvica-granted-breakthrough-therapy-designation-cgvhd/
`
`Marco Ricci
`
`June 30,
`2016
`
`AbbVie’s Imbruvica (ibrutinib) has gained its fourth Breakthrough Therapy
`Designation from the FDA – this time for the treatment of chronic graft versus host
`disease (cGVHD) after the failure of one or more lines of systemic therapy.
`
`The drug’s Breakthrough Therapy Designation (BTD) request came on the back of positive
`results from a preliminary phase 1b/2 study investigating its safety and efficacy in patients
`with steroid-dependent or refractory cGVHD.
`
`Preliminary results from the trial – previously presented at the European Society for Blood
`and Marrow Transplantation (ESBM) and ASCO – indicated that the drug was well tolerated,
`achieving a partial response in all five of the evaluable patients enrolled in the study
`following three months of treatment.
`
`“This fourth Breakthrough Therapy Designation from the FDA shows the promise of
`Imbruvica and its unique mechanism of action as a potential therapy beyond blood cancers,
`including chronic graft-versus-host-disease, a severe inflammatory condition with currently
`no approved therapies specifically for these patients,” said Danelle James, head of oncology
`at Pharmacyclics, joint developers of the drug. “We are committed to continuing to evaluate
`the potential benefit ibrutinib may offer in treating blood cancers, solid tumours and other
`health conditions with unmet medical needs.”
`
`1/2
`
`
`
`The FDA also granted ibrutinib Orphan Drug Designation (ODD) for the condition, a status,
`similar to BTD, that is intended to speed up the development of and access to a drug in a
`particular clinical setting based on the belief that it could be more effective than existing
`first line treatments.
`
`The drug had already achieved plenty of success in other fields, most recently through a
`BTD and ODD for the treatment of chronic lymphocytic leukaemia (CLL) or small
`lymphocytic lymphoma (SLL) in patients with a chromosome 17 deletion mutation.
`
`Data presented from the RESONATE and RESONATE-2 trials at this year’s ASCO meeting
`further boosted the profile of the drug in CLL and SLL, showing the drug could extend lives
`no matter in what line of therapy it was used.
`
`Prior to that, in February 2013, the drug was also given a BTD and ODD in refractory mantle
`cell lymphoma and Waldenström’s macroglobulinaemia.
`
`For cGVHD – a potentially life-threatening condition caused by immune cells present in a
`transplant attacking the donor’s body that can occur following allogeneic stem cell or bone
`marrow transplantation – ibrutinib gives a potential new treatment option to patients with a
`disorder that has no specifically designated therapies.
`
`Currently, extended treatment with prescribed glucocorticoids is the preferred treatment,
`however, research has shown that the long-term use of steroids can cause serious health
`complications.
`
`The drug is expected to be a blockbuster for AbbVie and co-developers Pharmacyclics and
`Janssen, with sales expected to reach $1 billion this year and $3 billion by 2020.
`
`2/2
`
`
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