30 January 2015 - Biopharmaceutical company Pharmacyclics (NasdaqGS:PCYC) reported on Thursday the receipt of full approval from the US Food and Drug Administration (FDA) for its single-agent IMBRUVICA (ibrutinib) in all lines of therapy as the first and only treatment for patients with Waldenstrom's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma blood cancer.

This is the fourth indication for IMBRUVICA which has received FDA Breakthrough Therapy Designation for this indication in February 2013, said the company.

The company added that IMBRUVICA is being jointly developed and commercialised with Janssen Biotech.

According to the company, the US FDA approval is based on results from a multi-centre, Phase II study that evaluated the efficacy and tolerability of IMBRUVICA in 63 patients with previously treated WM. IMBRUVICA demonstrated a response rate of 62% according to an Independent Review Committee. Very good partial responses (VGPR) of 11% and partial responses (PR) of 51% were observed.

IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK), the key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells, concluded the company.