Pharmacyclics, Inc, recently announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton’s tyrosine kinase 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.
With this submission, Pharmacyclics is also requesting Priority Review. If approved, ibrutinib would be the first available agent in a class of oral Bruton’s tyrosine kinase inhibitors. Pharmacyclics is jointly developing ibrutinib with Janssen.
The NDA submission follows the receipt of a Breakthrough Therapy designation from the FDA in February 2013 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). Ibrutinib has also been granted a Breakthrough Therapy designation for the treatment of patients with Waldenström’s macroglobulinemia.
“We are very excited having achieved this major milestone. This first NDA for ibrutinib was made possible in record time because of the continuous support and consultations we received from the FDA,” said Urte Gayko, PhD, Senior Vice President of Global Regulatory Affairs, Pharmacyclics. “We look forward to continuing to work with the FDA as they review the application for ibrutinib through the new Breakthrough Therapy designation process,” he added.
“The FDA submission is another important milestone for ibrutinib since we formed our strategic partnership with Pharmacyclics just 18 months ago,” said Peter F. Lebowitz, MD, PhD, Global Oncology Head, Janssen. “Both companies recognize that there is great unmet need among these patient populations, and together in close collaboration with the FDA, as part of its Breakthrough Therapy designation pathway, we have been able to accelerate the ibrutinib development program for the benefit of patients,” he said.
“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,” noted Bob Duggan, CEO and Chairman of Pharmacyclics. “As of today, we have initiated seven phase III studies together with our partner Janssen and have currently registered with the U.S. National Institute of Health 31 clinical trials using ibrutinib.” ■