The U.S. Food and Drug Administration today approved ibrutinib for treatment of patients with mantle cell lymphoma who have received at least one other form of therapy.
Approval came under the FDA's accelerated approval program for potential breakthrough drugs based on a single-arm pivotal phase II clinical trial led by Michael Wang, M.D., professor of Lymphoma/Myeloma.
"This is excellent news for mantle cell lymphoma patients," Wang says. "Ibrutinib is an oral drug taken once daily that has shown better response rates for patients than existing combination chemotherapy regimens and with much milder side effects."
Wang and colleagues reported clinical trial results in the New England Journal of Medicine on June 19.
The FDA announcement noted that the international clinical trial enrolled 111 patients and demonstrated a 66% overall response rate, with 17% of patients achieving a complete response and 49% partial responses. Median response duration was 17.5 months. Approval was based on overall response rate; a survival advantage has not yet been established.
Seventy-seven patients had stage 4 disease entering the trial and the median number of previous treatments received was three.