Pharmacyclics Submits NDA for ibrutinib Against MCL and SLL

Pharmacyclics has announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib.

The NDA is for ibrutinib as a treatment for patients with relapsed/refractory mantle cell lymphoma (MCL) or relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

The company submitted the NDA supported by data from Phase II studies in patients with both B-cell non-Hodgkin's lymphomas listed above. The company is seeking priority review.

Earlier this year the FDA gave Breakthrough Therapy Designation for ibrutinib as a monotherapy for the treatment of patients with relapsed/refractory MCL, and Breakthrough Therapy Designation for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p).

Said Dr. Urte Gayko, Senior Vice President of Global Regulatory Affairs, Pharmacyclics,

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. We look forward to continuing to work with the FDA as they review the application for ibrutinib through the new Breakthrough Therapy Designation process.

For up-to-date information on this study please visit the PCYC-04753 page at ClinicalTrials.gov

Source: Pharmacyclics