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Boehringer Ingelheim Pharmaceuticals, Inc. have 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.[i]
AML is an aggressive cancer of the bone marrow and blood.[ii] It accounts for 25 percent of all adult leukemias in the Western world[iii] and has one of the lowest survival rates of all leukemias.[iii] 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.[iv]
AML is primarily a disease of later adulthood; the average age of an AML patient is 65 years.[v] A common treatment approach for AML is intensive chemotherapy to induce disease remission, followed by consolidation/maintenance chemotherapy.[vi] However, many patients over 65 years of age - whose prognosis is typically poor[vii] - are ineligible for this approach, which involves large doses of chemotherapy over short periods of time,[vi] and therefore have even fewer treatment options. Volasertib* is currently being investigated in this specific patient population.[viii]
Results from a Phase II study, in newly diagnosed patients with AML considered ineligible for intensive remission induction therapy, demonstrated higher rates of objective response and an improvement in event-free survival in patients receiving volasertib in combination with low-dose cytarabine (LDAC) compared to patients receiving LDAC alone.[ix] The results were presented at the 54th American Society of Hematology (ASH) annual in December 2012.[ix]
These results led to the initiation in January 2013 of a Phase III trial, POLO-AML-2 (Clinical Trial Identifier: NCT01721876).[viii] This trial is designed to assess the efficacy and safety of volasertib in combination with LDAC, compared to placebo in combination with LDAC, in patients aged 65 or older with previously untreated AML, ineligible for intensive remission induction therapy.[viii] The trial is currently enrolling eligible patients.[viii] For more information please visit ClinicalTrials.gov.[viii]
Volasertib, an investigational inhibitor of polo-like kinase (Plk), is one of several late-stage compounds that Boehringer Ingelheim is currently evaluating in clinical trials for various solid tumors and hematological cancers. Boehringer Ingelheim is one of the first companies to advance Plk inhibitors into clinical development.
Volasertib is designed to inhibit the activity of Plk1, an enzyme in the Plk family that regulates cell division (mitosis). This inhibition is intended to result in prolonged cell cycle arrest, ultimately leading to cell death (apoptosis).[x]
For information about participating in a Boehringer Ingelheim clinical trial, please visit http://www.bicancertrials.com or call 1.866.725.7110. Healthcare providers interested in learning more about Boehringer Ingelheim clinical trials in oncology can visit http://www.inoncologyus.com for additional information.
*Volasertib is an investigational compound. Its safety and efficacy have not been established.
[i]U.S. Food and Drug Administration. Frequently Asked Questions: Breakthrough Therapies. Available here. Last Accessed: June 24, 2013.
[ii] Cleveland Clinic. Adult Acute Myeloid Leukemia. Available here. [Last Accessed: November 1, 2012]
[iii]Deschler B et al. Acute Myeloid Leukemia: Epidemiology and Etiology. Cancer. 2006. 2009-2107.
[iv]The Leukemia and Lymphoma Society. Facts. Spring 2013. Available here. Last Accessed: June 25, 2013
[v] National Marrow Donor Program. Acute Myelogenous Leukemia (AML). Available here. [Last Accessed: November 1, 2012]
[vi]Texas Oncology. Acute Myeloid Leukemia Induction, Overview. Available here. [Last Accessed: November 21, 2012]
[vii]The Leukemia and Lymphoma Society. Acute Myeloid Leukemia: Treatment Outcomes. Available here. Last Accessed: November 1, 2012
[viii]ClinicalTrials.gov. Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2). Available here. Last Accessed: June 24, 2013.
[ix]H. Döhner, Phase I/II study of volasertib (BI 6727), an intravenous Polo-like kinase (Plk) inhibitor, in patients with acute myeloid leukemia (AML): results from the randomized phase II part for volasertib in combination with low-dose cytarabine (LDAC) versus LDAC monotherapy in patients with previously untreated AML ineligible for intensive treatment. Oral Presentation at ASH Annual Meeting and Exposition 2012.
[x]Schöffski P. Polo-Like Kinase (PLK) Inhibitors in Preclinical and Early Clinical Development in Oncology. Oncologist. 2009;14(6):559-570.
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Ingelheim, Boehringer. "Volasertib* receives FDA Breakthrough Therapy Designation for treatment of patients with acute myeloid leukaemia." Medical News Today. MediLexicon, Intl., 19 Sep. 2013. Web.
12 Dec. 2013. <http://www.medicalnewstoday.com/releases/266272>
Ingelheim, B. (2013, September 19). "Volasertib* receives FDA Breakthrough Therapy Designation for treatment of patients with acute myeloid leukaemia." Medical News Today. Retrieved from
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