Ibrutinib Granted Expanded Indication for Chronic Graft Versus Host Disease

The FDA expanded the indications of ibrutinib to include the treatment of adult patients with cGVHD who have failed at least one prior therapy

The FDA expanded the indications of ibrutinib to include the treatment of adult patients with cGVHD who have failed at least one prior therapy

It's not just for cancer anymore.

Officials with the US FDA have expanded the approval of the cancer drug ibrutinib (Imbruvica, Pharmacyclics) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments.

The FDA based the approval in part on results from the open-label, multicenter, single-arm PCYC-1129-CA trial, created to evaluate the efficacy and safety of 420 mg ibrutinib once daily for 42 patients with chronic GVHD who failed first-line corticosteroid therapy and required additional therapy.

The agency's nod came a full month ahead of the anticipated PDUFA date for Imbruvica, which had priority review, as well as orphan and breakthrough therapy designations for cGVHD. The primary endpoint was cGVHD response based on the 2005 NIH consensus response criteria. The overall response rate was 67%, and the median time-to-response coinciding with the first scheduled response assessment was 12.3 weeks.

Most patients (88%) had at least two organs involved at baseline, the most common of which were the mouth (86%), skin (81%) and gastrointestinal tract (33%). Almost half of the patients (48%) had responses lasting ≥5 months. "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".

Twenty-four percent of patients discontinued treatment due to AEs.

It's only recently - within the last couple of decades - that cGVHD has been linked to B cells. Imbruvica appears able to target both, through its well-known inhibition of BTK - a protein that plays a role in signaling B cells needed by specific cancer cells to multiply and spread - as well as its role in blocking interleukin-2-inducible T-cell kinase, or ITK, which is linked to subsets of T helper cells. Ibrutinib was previously approved by the FDA to treat chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma with 17p deletion, Waldenström's macroglobulinemia, marginal zone lymphoma, and mantle cell lymphoma.

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