Pharmacyclics files Imbruvica sNDA for Waldenstrom's macroglobulinemia

US drugmaker Pharmacyclics (Nasdaq: PCYC) has submitted a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Imbruvica (ibrutinib) in the treatment of Waldenstrom’s macroglobulinemia (WM).

The filing is based on data from a Phase II study evaluating the use of Imbruvica in patients with Waldenstrom’s macroglobulinemia, which was led by Steven Treon from the Dana-Farber Cancer Institute. Imbruvica, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ).

WM is a slow-growing, currently incurable, rare type of B-cell lymphoma for which no established standard of care - or approved therapeutic - exists. There are around 1,000 to 1,500 new cases each year and a prevalence of 12,000 in the USA, and the median age at diagnosis is 60 to 70 years of age.