FDA approves NDA filing for ibrutinib inhibitor in two B-cell malignancies

Aug 29 2013

Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that the U.S. Food and Drug Administration (FDA)  has accepted for filing its New Drug Application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). On June 28, 2013 Pharmacyclics submitted a New Drug Application (NDA) under section 505(b) of the Food, Drug & Cosmetic Act for ibrutinib. On Aug 27, 2013 the FDA notified Pharmacyclics that they have completed their filing review and determined that the application is sufficiently complete to permit a substantive review. The FDA's acceptance of the NDA triggers a $75 million milestone payment to Pharmacyclics under its Collaboration Agreement with Janssen Biotech Inc.

"We are very excited to have received the official FDA acceptance of our first NDA filing for ibrutinib," said Dr. Urte Gayko, Senior Vice President of Global Regulatory Affairs, Pharmacyclics. "We look forward to continuing to work with the FDA as they complete their review of the ibrutinib application which includes the new Breakthrough Therapy Designation process."