FDA Approves Imbruvica for the Treatment of Marginal Zone Lymphoma in Some Patients

The FDA has approved Imbruvica (ibrutinib) for the treatment of marginal zone lymphoma (MZL) in patients who require systemic therapy, or in those patients who have received at least 1 anti-CD20-based therapy. The approval was based on the product’s apparent overall response rate in a phase 2 trial.

The PCYC-1121 trial assessed the safety and efficacy of Imbruvica in 63 patients with MZL, who had received at least 1 prior therapy. Their responses to the investigational product were assessed by an independent review committee, utilizing criteria from the International Working Group criteria for malignant lymphoma. There was a 46% overall response rate in patients, and 3.2% of participants achieved complete responses.

"Patients with relapsed/refractory marginal zone lymphoma are in critical need of treatment options to manage living with this rare, serious blood cancer," Ariela Noy, MD, Hematologic Oncologist at Memorial Sloan Kettering Cancer Center and lead investigator of the study, said in a press release. "This approval of Imbruvica represents a welcome new oral option for the MZL community and is the first approved therapy for these patients."

Some of the adverse effects associated with Imbruvica are thrombocytopenia, fatigue, anemia, diarrhea, bruising, musculoskeletal pain, and nausea.