Ibrutinib Submitted to FDA for Treatment of Marginal Zone Lymphoma

The U.S. Food and Drug Administration received a new drug application (NDA) for ibrutinib for the treatment of marginal zone lymphoma (MZL). If approved, it could become the first treatment with a specific indication for this rare disease. MZL accounts for 12 percent of all cases of non-Hodgkin lymphoma in adults.

Data from the international, multicenter, open-label, phase II PCYC-1121-CA trial was submitted along with the NDA. This trial assessed the use of ibrutinib in 63 patients with MZL – including splenic MZL, nodal MZL, and extranodal MZL – who had received at least one prior therapy. Patients received 560 mg of ibrutinib orally once daily until progression or unacceptable toxicity. Outcomes have not yet been reported.

Sources: Janssen press release, September 26, 2016.