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FDA Breakthrough Therapy Designation: Boehringer Ingelheim Receives #23

September 17, 2013

Boehringer Ingelheim announces on September 17, 2013, that the FDA grants non-orphan drug Volasertib the coveted Breakthrough Therapy Designation (BTD). Volasertib is being evaluated for the treatment of patients aged 65 or older, with previously untreated Acute Myeloid Leukemia (AML) and ineligible for intensive remission induction therapy (see below).

AML Facts

•   Aggressive bone marrow and blood cancer
•   Average age of AML patient is 65 years
•   25% of all leukemias in Western world
•   One of the lowest survival rates of all leukemias
•   Approximately 14,590 Americans will be diagnosed with AML in 2013
•   Approximately  10,370 Americans will die from AML in 2013.

Doctors will usually begin treatment right after the patient is diagnosed with AML, since it can get worse very quickly. The goal of AML treatment is to achieve complete remission. There are 2 phases of AML treatment :

•   Induction Therapy
•   Consolidation or Postremission Therapy.

Induction Therapy occurs at the initial diagnosis of AML. The objective is to stop leukemic cells from multiplying and to decrease the percentage of existing leukemic cells. The goal of Consolidation Therapy is to “reactivate one’s immune system” with additional chemotherapy or a bone marrow transplant.

Volasertib is being investigated for a specific population – patients over 65 with a poor prognosis and who are not eligible for intensive chemotherapy over short periods of time. A Phase III clinical trial (POLO-AML-2) is currently enrolling eligible patients from this specific patient population.

“Volasertib is designed to inhibit the activity of Plk … Plk1 is an enzyme that regulates cell division (mitosis). This inhibition results in cell cycle arrest and ultimately cell death …”.

The latest “FDA Breakthrough Therapy Designation Chart” Blog Post, is located at URL, so please bookmark.

The latest “FDA Breakthrough Therapy Designation Statistics Chart” Blog Post is located at URL, so please bookmark.


AML Alliance

Leukemia & Lymphoma Society

**  OBR article titled, “FDA’s new breakthrough therapy designation: What does it mean for pricing and Market Access ?”.

Please Note: “A group of three balloons on ribbons” JPEG by AJ (Open clip Art Library image’s page) [see page for license] | Wikimedia Commons.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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