Ibrutinib Submitted to FDA for Treatment of Marginal Zone Lymphoma

The FDA received a supplemental new drug application (sNDA) 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.

The sNDA is based on data from the international, multicenter, open-label, phase II PCYC-1121-CA trial, which assessed the use of single-agent ibrutinib in 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. The study’s primary endpoint is overall response rate (ORR), as determined by an independent review committee. Secondary endpoints include duration of response and overall survival. Outcomes have not yet been reported.

Ibrutinib previously was approved by the FDA for the treatment of patients with mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic leukemia, and Waldenström macroglobulinemia.

Source: Janssen press release, September 26, 2016.