FDAnews Drug Daily Bulletin

Phase III Trial of Janssen’s Imbruvica Stopped Early on Positive Results

Jan. 9, 2013

Janssen has stopped a Pharmacyclics-sponsored Phase III trial of its lymphoma drug Imbruvica early on the recommendation of an independent data monitoring committee that found the drug showed evidence of clinical benefit and tolerable safety, the drugmaker announced Tuesday.

Data from the international, randomized open-label PYCY-1112-CA study of 391 patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) showed a significant difference in progression-free survival compared to the control.

Imbruvica (ibrutinib) was approved in the U.S. in November for mantle cell lymphoma. Janssen is seeking the European Medicines Agency’s approval to market the drug in the EU for adult patients with relapsed CLL/SLL or relapsed or refractory mantle cell lymphoma. — Lena Freund

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