IMBRUVICA® sNDA Submitted to the FDA for Marginal Zone Lymphoma (MZL)

Janssen Research & Development, LLC has announced that a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA®) has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy. The filing is based on data from the multi-center, open-label Phase 2 PCYC-1121 trial assessing the use of ibrutinib, a BTK inhibitor, in patients with MZL who have received at least one prior therapy. IMBRUVICA is jointly developed and commercialized by Janssen and Pharmacyclics LLC, an AbbVie company.

"We are encouraged by the results of this study of ibrutinib in yet another type of B-cell malignancy," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. "This FDA submission represents an exciting and important step towards a potential new treatment option for MZL patients who currently have a great unmet need. Currently there are no therapies approved for this rare form of cancer."

The PCYC-1121 international trial enrolled 63 patients with MZL who had received at least one prior therapy, including splenic MZL (SMZL), nodal MZL (NMZL) and extranodal MZL (EMZL). Patients received ibrutinib 560mg orally, once daily until progression or unacceptable toxicity. The primary endpoint of the study was overall response rate as assessed by an Independent Review Committee. Key secondary endpoints included duration of response and overall response rate. The data have been submitted for publication in a peer-reviewed journal and presentation at an upcoming medical conference. More information about the study can be found on (NCT01980628).

IMBRUVICA is currently approved to treat patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) including patients with 17p deletion, patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and patients with Waldenström's macroglobulinemia (WM). Accelerated approval was granted for MCL based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Janssen and Pharmacyclics are continuing an extensive clinical development program for IMBRUVICA, including Phase 3 study commitments in multiple patient populations.


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