New Drug Application for Ibrutinib Submitted to FDA for B-Cell Malignancies

July 2013, Vol 4, No 6 - FDA Approvals, News & Updates


A New Drug Application for the oral Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib (Janssen Biotech/Pharmacyclics) was submitted to the US Food and Drug Administration (FDA) for the treatment of patients with B-cell malignancies, specifically for previously treated patients with chronic lymphocytic leukemia (CLL) or with small lymphocytic lymphoma (SLL), and for previously treated patients with mantle-cell lymphoma (MCL).

The New Drug Application from the manufacturer is based on data from 2 pivotal, phase 2 clinical trials, one in patients with relapsed and/or refractory CLL/SLL (PCYC-1102), and the other in patients with relapsed and/or refractory MCL (PCYC-1104).

If approved, ibrutinib would be the first agent in the class of oral BTK inhibitors. In addition, ibrutinib is one of the first drugs to be submitted for FDA approval via the new Breakthrough Therapy Designation pathway. (July 10, 2013)