Boehringer Ingelheim gets Breakthrough designation for leukemia candidate

German pharma major Boehringer Ingelheim has gained Breakthrough Therapy Designation from the US Food and Drug Administration for its investigational leukemia agent volasertib.

Volasertib is 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.

Sabine Luik, Boehringer Ingelheim’s senior vice president of medicine & regulatory affairs, said: “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. 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.”