Pharmacyclics announced that the enrollment target of 350 patients for its Phase III study using ibrutinib monotherapy versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, was achieved on April 3. As of today, additional 41 patients were screened and are allowed to participate in this study which has now been officially closed to enrollment. The primary endpoint of this study is to demonstrate a clinically significant improvement in progression-free survival with ibrutinib when compared to ofatumumab. A pre-defined number of progression events will trigger an interim analysis. The company expects to have a read out from the interim analysis during 1Q14. As previously announced Pharmacyclics expects to file a New Drug Application with the FDA for the use of ibrutinib in patients with relapsed or refractory MCL prior to year-end. In the time before a potential U.S. marketing approval Pharmacyclics will strive to provide early access to ibrutinib under an Early Access Program.
- Health Care Industry