Pharmacyclics: FDA Accepts NDA Filing For Ibrutinib In Two B-cell Malignancies

(RTTNews) - Pharmacyclics Inc. (PCYC) announced that the U.S. Food and Drug Administration or FDA has accepted for filing its New Drug Application or NDA for the investigational oral Bruton's tyrosine kinase or BTK inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma or MCL and previously treated chronic lymphocytic leukemia or CLL/small lymphocytic lymphoma or SLL.

On June 28, 2013 Pharmacyclics submitted a New Drug Application for ibrutinib. On August 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, the company said.

CLL, a B-cell malignancy, is a slow-growing blood cancer of the white blood cells (lymphocytes), most commonly from B-cells. CLL is the second most common adult leukemia. Approximately 16,000 patients in the US are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the U.S. CLL is a chronic disease that predominantly occurs in the elderly with a five-year survival of approximately 82 percent.