FDA Awards Volasertib Breakthrough Therapy Status for Acute Myeloid Leukemia


FDA-Breakthrough-Therapy-Status-Awarded-to-VolasertibOn September 17, 2013 the FDA announced that Breakthrough Status was awarded to Volasertib. Currently marketed by Boehringer Ingelheim, this Volasertib breakthrough designation by the FDA is encouraging for patients suffering from acute myeloid leukemia. Volasertib is unique as it is a selective and powerful polo-like kinase inhibitor. Although Volasertib is currently an unapproved and investigational compound, the mode of action of this drug is proving to be formidable and efficacious in studies.

A Phase 2 study of Volasertib, conducted by Boehringer Ingelheim, has offered positive data regarding the treatment of patients with acute myeloid leukemia. Approximately 42 patients in the Phase 2 study were administered Volasertib alongside a low dose of Cytarabine. These patients were compared to 45 clinical trial participants who were given low dose Cytarabine CAS# 147-94-4, a chemotherapeutic standard care treatment, and no additional medications. With the objective response from the patients being the primary endpoint in this Phase 2 study, evidence was clear in supporting the use of Volasertib for patients. The objective response was apparent in 31 percent of the patients who were dosed with both Volasertib and Cytarabine, while roughly 13 percent of the participants who received Cytarabine only met the objective response endpoint. Additionally, the clinical trial participants who were administered both Volasertib and Cytarabine had an extended survival time of 8 months. Those patients who were dosed with Cytarabine alone had an extended survival rate of 5.2 months.

CytarabineOlder patients in particular are unable to tolerate high doses of chemotherapy, leaving them at risk for complications and early death from acute myeloid leukemia. The advent of the Volasertib breakthrough opens up new pathways not only for the elderly population, but also for the 14,590 new cases of patients with acute myeloid leukemia in the U.S. each year.

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