Clinical-stage biopharmaceutical company Pharmacyclics' new drug application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, has been accepted by the US FDA for two B-cell malignancy indications.
BTK is a key mediator of at least three critical B-cell pro-survival mechanisms, including regulation of apoptosis, adhesion, and cell migration and homing, which occur in parallel.
The two B-cell malignancy indications include previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Pharmacyclics Global Regulatory Affairs senior vice president Dr Urte Gayko said, "We look forward to continuing to work with the FDA as they complete their review of the ibrutinib application which includes the new Breakthrough Therapy Designation process."
In December 2011, Janssen Biotech and Pharmacyclics entered a collaboration and license agreement to co-develop and co-commercialize ibrutinib.
As part of the collaboration agreement, the FDA's acceptance of the NDA will generate a $75m milestone payment to Pharmacyclics.
Currently, seven Phase III trials have been initiated with ibrutinib to date and a total of 31 trials are currently registered.
The investigational agent is being studied alone or in combination in several B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Waldenstrom's macroglobulinemia and multiple myeloma.
