Boehringer Ingelheim Pharmaceuticals today announced the FDA has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), being evaluated for the treatment of patients aged 65 or older with previously untreated acute myeloid leukemia (AML), ineligible for intensive remission induction therapy.
"This FDA Breakthrough Therapy designation provides Boehringer Ingelheim the opportunity to engage in an ongoing dialogue with the FDA to help expedite the development of volasertib as a potential treatment option for these patients with AML," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. "Volasertib is one of many investigational compounds in Boehringer Ingelheim's growing oncology pipeline and is an example of our commitment to exploring treatment approaches with the goal of improving patient outcomes."
The Breakthrough Therapy designation process was established by the FDA in July 2012 and is intended to facilitate and expedite the development and review of drugs for serious or life-threatening conditions if preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
AML is an aggressive cancer of the bone marrow and blood. It accounts for 25 percent of all adult leukemias in the Western world and has one of the lowest survival rates of all leukemias. In 2013, it is estimated there will be 14,590 new cases of AML diagnosed in the U.S. and 10,370 deaths from the disease.