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BerGenBio drug picks up US FDA fast-track tag for bone marrow cancer

BerGenBio ASA said the U.S. Food and Drug Administration granted fast-track designation to bemcentinib for treating a type of cancer that affects blood and bone marrow.

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Acute myeloid leukemia, or AML, is diagnosed in more than 20,000 patients in the U.S. per year and is quickly lethal. Successful treatment of the disease requires intensive therapy or bone marrow transplantation, and there is demand for less taxing treatments in patients who are ineligible.

Bemcentinib is being developed to treat AML in patients over 70 years old whose disease has relapsed, the Norway-based biotechnology company said in an Oct. 22 press release.

"A majority of AML patients are unable to tolerate intensive chemotherapy and have limited treatment options, particularly if established first-line therapies fail," BerGenBio CEO Richard Godfrey said at The 2019 American Society of Clinical Oncology meeting in June.

The FDA's fast-track program expedites the review of new drugs that show the potential to address an unmet medical need for serious conditions. Incentives include frequent meetings with the FDA and priority review of the marketing application.