Imbruvica ibrutinib: Completed Phase III enrollment

Pharmacyclics disclosed in its 1Q14 earnings that in 4Q13 Johnson & Johnson's Janssen Research & Development LLC unit completed enrollment of 280 patients who received >=1 prior rituximab-containing chemotherapy regimen in the open-label, international Phase III RAY (MCL3001) trial comparing 560 mg oral ibrutinib once daily in 21-day cycles vs. IV Torisel temsirolimus. Patients in the Torisel arm will receive 175 mg of the drug on days 1, 8 and 15 in the first cycle followed by 75 mg doses on days 1, 8, and 15 of each cycle thereafter.

Ibrutinib has accelerated approval as Imbruvica in the U.S. to treat relapsed or refractory MCL in patients who have received >=1 prior therapy and to treat relapsed or refractory chronic lymphocytic leukemia (CLL). In April, Pharmacyclics submitted an sNDA to FDA for Imbruvica based on data from the Phase III RESONATE (PCYC-1112-CA) trial in patients with relapsed or refractory CLL or small cell lymphocytic lymphoma (SLL) in patients who have received >=1 prior therapy (see BioCentury, April 14). In October, Johnson & Johnson submitted an MAA to EMA for ibrutinib to treat MCL and CLL or SLL. ...