Boehringer Receives Breakthrough Designation for AML Treatment


Boehringer Ingelheim Pharmaceuticals, Inc. is reporting that the FDA has granted Breakthrough Therapy designation to the company's investigational treatment for acute myeloid leukemia (AML).

That treatment is volasertib, an inhibitor of polo-like kinase (Plk). Boehringer is evaluating the treatment for patients aged 65 or older with previously untreated AML who are not eligible for intensive remission induction therapy.

Said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc.:

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.

Breakthrough Therapy designation is designed to streamline 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.

A less intensive treatment

About one quarter of all adult leukemia diagnoses in the West are AML. It is an aggressive tumor of the bone marrow, and it is unlike other leukemias in that it does not enjoy a high rate of remission or cure.

This is especially true among older people, who are the ones typically diagnosed with AML. Because many can't withstand the intensive treatments, Boehringer began pursuing this treatment option.

According to the company,

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).

Source: Boehringer

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