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Moleculin’s Annamycin Gains FDA Orphan Drug Status

January 4, 2021

Moleculin’s anthracycline chemotherapy drug annamycin has earned its second Orphan Drug designation from the FDA, this time for the treatment of soft-tissue sarcomas.

The Houston, Tex.-based biotech previously earned Orphan Drug designation for annamycin for treating relapsed or refractory acute myeloid leukemia. The drug is designed to avoid multidrug-resistance mechanisms with little to no cardiotoxicity.

The agency recently gave Moleculin the go-ahead to begin a phase 1b/2 clinical trial of annamycin for patients with soft-tissue sarcoma that has metastasized to the lungs after first-line therapy.

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