In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|August 3, 2017
FDA Grants Approval of Treatment for cGVHD
Author(s)BioPharm International Editors
FDA has approved Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD), a new indication for the anti-cancer drug.
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On August 2, 2017, FDA approved Imbruvica (ibrutinib) to treat chronic graft versus host disease (cGVHD) following the failure of one or more treatments. This is a new indication for the drug, which was previously approved by FDA in November 2013 and is indicated for mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma (MZL).
“Patients with cGVHD who do not respond to other forms of therapy-typically corticosteroids to suppress their immune system-now have a treatment option specifically indicated to treat their condition,” said Richard Pazdur, MD, FDA’s Oncology Center of Excellence director and acting director of the Office of Hematology and Oncology Products of CDER, in a company press release. “This approval highlights how a known treatment for cancer is finding a new use in treating a serious and life-threatening condition that may occur in patients with blood cancer who receive a stem cell transplant.”
Following a stem cell transplant from blood or bone marrow used to treat specific blood or bone cancers called hematopoietic stem cell transplantation (HSCT), this condition is the result of HSCT cells attacking healthy cells in the tissue of recipients. Reportedly, 30-70% of patients who receive HSCT develop the condition, which produces symptoms such as skin rashes and mouth ulcers and affects organ health.
The drug, a partnership between AbbVie and Janssen Biotech, a Johnson & Johnson company, shows potential in the development of other therapeutic approaches.
Lori Styles, MD, senior medical director and GVHD program clinical lead at Pharmacyclics, an AbbVie company, said in a company press release: "This approval is an indicator of what is possible with Imbruvica, and we remain excited about the clinical utility of Imbruvica in other disease areas. We continue to explore the full potential of this therapy and believe our comprehensive clinical trial program will help advance patient care."
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