January 19, 2017 – The FDA announced the approval of ibrutinib to treat patients with relapsed/refractory marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. MZL is a slow-growing B-cell lymphoma occurring in white blood cells (lymphocytes) at the edges of lymph nodes and various tissues, including the stomach, salivary glands, thyroid gland, eyes, lungs and spleen.1 MZL accounts for approximately 12 percent of all cases of non-Hodgkin’s lymphoma in adults.1
The approval in MZL is based on data from the Phase 2, open-label, multi-center, single-arm PCYC-1121 study, which evaluated the safety and efficacy of ibrutinib in MZL patients who require systemic therapy and have received at least one prior anti-CD20-based therapy. The data were previously presented at the American Society of Hematology (ASH) Annual Meeting (December 2016). You can view the abstract Single-Agent Ibrutinib Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Phase 2 Study here.
“In the Phase 2 trial, ibrutinib demonstrated impressive response rates and duration of response in relapsed/refractory marginal zone lymphoma patients,” said Ariela Noy, M.D., Hematologic Oncologist at Memorial Sloan Kettering Cancer Center in New York and lead investigator of the study. ““Patients with relapsed/refractory marginal zone lymphoma are in critical need of treatment options to manage living with this rare, serious blood cancer. The hematology-oncology community welcomes a new oral option like ibrutinib, which helps fill a significant treatment gap for previously treated MZL patients who are in need of non-chemotherapy options.”
Overall, the safety data from this study was consistent with the known safety profile of ibrutinib in B-cell malignancies.
- Lymphoma Research Foundation. “Marginal Zone Lymphoma.” Available at: http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6554677 Accessed January 19, 2017.