Pharmacyclics Says FDA Okays Imbruvica - Quick Facts

(RTTNews) - Pharmacyclics Inc. (PCYC) said Wednesday the US Food and Drug Administration has approved IMBRUVICA (ibrutinib) as a single agent for the treatment of patients with mantle cell lymphoma, or MCL, who have received at least one prior therapy. The company said IMBRUVICA is commercially available immediately.

This indication is based on overall response rate, and an improvement in survival or disease-related symptoms has not been established, the company said.

IMBRUVICA is one of the first treatments to receive FDA approval via the Breakthrough Therapy Designation pathway. Pharmacyclics completed its New Drug Application submission to the FDA in late June 2013 and received approval just over four months later.

IMBRUVICA is a new agent that inhibits the function of Bruton's tyrosine kinase, a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells. IMBRUVICA blocks signals that stimulate malignant B cells to grow and divide uncontrollably.