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Bristol Myers Squibb Wins FDA Approval for Leukemia Drug

By Eric Volkman – Sep 1, 2020 at 11:42PM

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Onureg is aimed at treating a particularly aggressive form of the disease.

While the world awaits treatments and vaccines targeting the SARS-CoV-2 coronavirus still ravaging the world, drug developers and regulators are getting on with other business. One illustration of this occurred on Tuesday, when the Food and Drug Administration granted approval to Bristol Myers Squibb (BMY 0.96%) for its Onureg leukemia drug.

Onureg was given the green light for, in the company's words "the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy." The medication is administered orally, once per day.

Red blood cells.

Image source: Getty Images.

AML is an aggressive blood and bone marrow cancer in which the body produces abnormal myeloblasts, platelets, or red blood cells. Myeloblasts are a form of white blood cell. According to Bristol Myers Squibb, AML is one of the most common types of acute leukemias in adults.

"This milestone is representative of our commitment to helping patients with hard-to-treat cancers live longer, and the approval of Onureg as an oral therapy option for patients is more relevant now than ever as the world continues to navigate the COVID-19 pandemic," the company quoted its CEO Giovanni Caforio as saying.

Onureg had a long development path. It is the product of more than 10 years of research, and it underwent a total of 13 pre-clinical and clinical trials.

In May, Bristol Myers Squibb filed a Marketing Authorization Application to the European Union's European Medicines Agency for the same indication. It is currently under review.

Eric Volkman has no position in any of the stocks mentioned. The Motley Fool owns shares of and recommends Bristol Myers Squibb. The Motley Fool has a disclosure policy.

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