CRO WuXi PharmaTech, with operations in China and the U.S., said its subsidiary Shanghai SynTheAll (STA) Pharmaceutical has entered into a supply arrangement with Pharmacyclics. This follows a successful multiple-year development and clinical manufacturing partnership that supported Pharmacyclics with an expedited NDA submission and final approval by the FDA of Imbruvica on Nov. 13, for treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established.
Imbruvica is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is 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 tell malignant B cells to grow and divide uncontrollably. Imbruvica has been granted three Breakthrough Therapy designations by the FDA, a first for an oncology drug. Nine phase III clinical trials have been initiated with Imbruvica and 37 clinical trials are currently registered on www.clinicaltrials.gov.