Janssen Research & Development announced that it has submitted a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) to the U.S. Food and Drug Administration (FDA), requesting its approval be extended to treat marginal zone lymphoma (MZL) patients who require systemic therapy.
If approved for MZL, Imbruvica will become the first approved treatment for this rare disease. Currently, there are no approved therapies or established standards of care for MZL patients.
MZL is a B-cell lymphoma that arises from white blood cells (known as lymphocytes) at the margins, or edges, of lymph nodes and different tissues, including the stomach, salivary glands, thyroid gland, eyes, lungs, and spleen. MZL accounts for nearly 12 percent of all cases of non-Hodgkin’s lymphomas in adults, and the median age at diagnosis is about 65 years old.
Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK), which transmits signals telling B-cells to mature and produce antibodies. Because these antibodies are used by specific cancer cells to multiply and spread, Imbruvica aims to prevent cancer progression.
The trial enrolled 63 patients with several types of MZL, including splenic MZL, nodal MZL, and extranodal MZL. Participants received a once daily, oral Imbruvica (560 mg) dose until disease progression or unacceptable toxicity. The study’s primary endpoint was overall response rate (ORR), as determined by an independent review committee. Important secondary endpoints included duration of response and overall survival.
“We are encouraged by the results of this study of ibrutinib in yet another type of B-cell malignancy,” Peter Lebowitz, MD, PhD, head of Global Oncology at Janssen, said in a press release. “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.”
Janssen has also submitted the trial’s data for publication in a peer-reviewed journal, and plans to present the data at an upcoming medical conference. Furture plans also include a Phase 3 clinical trial evaluating ibrutinib in multiple patient populations.
Imbruvica is being jointly developed by Janssen and Pharmacyclics, an AbbVie company. It is currently approved in the U.S. for the treatment of chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL), mantle cell lymphoma (MCL), and Waldenström’s macroglobulinemia (WM).