Pharmacyclics Submits NDA For Investigational Oral BTK Inhibitor Ibrutinib

(RTTNews) - Pharmacyclics, Inc. (PCYC), a clinical-stage biopharmaceutical company, Wednesday said that it submitted a New Drug Application or NDA to the US Food and Drug Administration or FDA, for an investigational oral Bruton's tyrosine kinase or BTK inhibitor, ibrutinib. The compound will be investigated for two relapsed/refractory B-cell malignancy indications - mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma.

The submission comes after the data from Phase II studies in patients with B-cell malignancy indications, and the company is further requesting a Priority Review.

"These past months have been enormously active and productive for Pharmacyclics and our ibrutinib partner, Janssen. We received our first of three Breakthrough Therapy Designations just this past February and since then published various clinical results in patients with CLL del17p and also in patients with Waldenstrom," said Bob Duggan CEO and Chairman of Pharmacyclics.

In April, the compan has completed enrollment of its first Phase III study and results of two of trials were published in June.