Boehringer Ingelheim announced that the FDA has granted Orphan Drug designation to volasertib for acute myeloid leukemia (AML). Volasertib is an investigational inhibitor of polo-like kinase (Plk), designed to inhibit the activity of Plk1, an enzyme in the Plk family that regulates cell division resulting in prolonged cell cycle arrest, ultimately leading to cell death.

Volasertib is currently being evaluated in a Phase 3 clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for intensive remission induction therapy. Other clinical trials are also evaluating the use of volasertib for various solid tumors and hematological cancers.

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Previously in 2013, volasertib was granted Breakthrough Therapy designation by the FDA. Boehringer Ingelheim plans on publishing the Phase 1/2 trial data that was used in support of the Breakthrough Therapy Designation later this year.

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