Pharmacyclics, a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases, based in Sunnyvale, Calif., has submitted a New Drug Application (NDA) to the FDA for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

The submission was based on data from phase II studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. Pharmacyclics, which is developing ibrutinib with Janssen, also is requesting Priority Review.

The NDA submission follows the receipt of a Breakthrough Therapy Designation from the FDA in February for ibrutinib as a monotherapy for the treatment of patients with relapsed/refractory MCL, and receipt of a second Breakthrough Therapy Designation for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p).

"This first NDA for ibrutinib was made possible in record time because of the continuous support and consultations we received from the FDA," said Dr. Urte Gayko, senior vice president of global regulatory affairs, Pharmacyclics.

“In April we completed enrollment of our first phase III study,” said Bob Duggan, chief executive officer and chairman of Pharmacyclics. "Thus far, more than 1,600 patients have been treated in our studies with ibrutinib, and we are making excellent progress in the development and preparation for commercialization of this investigational drug. As of today, we have initiated seven phase III studies and have currently registered with the US NIH 31 clinical trials using ibrutinib.”