Moleculin Biotech comments on FDA approvals for AML drugs

Moleculin Biotech specializes in developing anti-cancer drug candidates.
Moleculin Biotech specializes in developing anti-cancer drug candidates. | Contributed image

Moleculin Biotech Inc. recently released comments regarding recent FDA approvals for new drugs that treat acute myeloid leukemia.

"The recent approvals of three new drugs (Rydapt, Vyxeos and Idhifa) for the treatment of AML are exciting, since they provide additional options for treatments in defined subpopulations, and because they help underscore the magnitude of the potential opportunity for Annamycin, which we will be studying for relapsed or refractory AML,” Moleculin CEO Walter Klemp said in a statement.

Klemp noted that Rydapt is only approved for certain patients – those with a specific gene mutation. Additionally, the drug can only be used in combination with standard chemotherapy treatments. Meanwhile, Vyexos also has its limitations.

“Vyxeos is approved as an option to the standard of care, but only for specific AML patients, namely those with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes. Jazz Pharmaceuticals purchased this drug in their $1.5 billion acquisition of Celator Pharmaceuticals,” Klemp said.

Klemp also noted the importance of Idhifa’s accelerated clinical trial design showing a 19 percent response rate in patients with relapsed or refractory AML and IDH2 mutation.

Moleculin Biotech is a preclinical pharmaceutical company that specializes in developing anti-cancer drug candidates. It often licenses with the University of Texas system on behalf of the MD Anderson Cancer Center.

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