Catalent Pharma Solutions, a provider of development solutions and advanced delivery technologies for drug, biologic and consumer health products, has signed an agreement with Pharmacyclics for the oncology drug IMBRUVICA (Ibrutinib). This follows a successful multiple-year development and clinical manufacturing partnership that aided Pharmacyclics' expedited NDA submission and approval by the FDA.
Catalent will provide drug product capsules for both commercial supply and ongoing clinical trials. After review by the FDA, IMBRUVICA received approval on Nov. 13, for treatment of patients with mantle cell lymphoma (MCL) 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. IMBRUVICAwas granted three Breakthrough Therapy designations by the FDA, intended to expedite the development and review of drugs for serious or life-threatening conditions, a first for an oncology drug. To date, seven phase III trials have been initiated with IMBRUVICA and a total of 30 trials currently are registered on www.clinicaltrials.gov.
The agreement was reached after a successful FDA Pre-Approval Inspection (PAI) at Catalent's site in Kansas City, Mo., that resulted in zero observations. The facility provides a range of fully integrated support services, from formulation development and analytical testing, to clinical and commercial scale manufacturing and packaging of a variety oral dose forms.