FDA News

FDA grants fast track designation to Annamycin for relapsed/refractory acute myeloid leukemia

The FDA granted fast track designation to Annamycin for treatment of patients with relapsed or refractory acute myeloid leukemia, according to the agent’s manufacturer.

Annamycin (Moleculin Biotech) is a liposome-formulated anthracycline designed to eliminate cardiotoxicity and avoid multidrug resistance mechanisms associated with other approved anthracyclines.

The agent is being evaluated in separate phase 1 and phase 2 trials in the United States and Europe.

Studies in animal models showed the agent to be noncardiotoxic. Trials that included patients with leukemia showed the agent was associated with fewer dose-limiting toxicities than typically experienced with doxorubicin, according to Moleculin.

“We are thrilled that Annamycin has been granted fast track designation,” Walter Klemp, Moleculin’s chairman and CEO, said in a company-issued press release. “Not only does this make us eligible for accelerated approval and priority review, but it serves as an important validation of the significant unmet need we are trying to address.”

The FDA granted fast track designation to Annamycin for treatment of patients with relapsed or refractory acute myeloid leukemia, according to the agent’s manufacturer.

Annamycin (Moleculin Biotech) is a liposome-formulated anthracycline designed to eliminate cardiotoxicity and avoid multidrug resistance mechanisms associated with other approved anthracyclines.

The agent is being evaluated in separate phase 1 and phase 2 trials in the United States and Europe.

Studies in animal models showed the agent to be noncardiotoxic. Trials that included patients with leukemia showed the agent was associated with fewer dose-limiting toxicities than typically experienced with doxorubicin, according to Moleculin.

“We are thrilled that Annamycin has been granted fast track designation,” Walter Klemp, Moleculin’s chairman and CEO, said in a company-issued press release. “Not only does this make us eligible for accelerated approval and priority review, but it serves as an important validation of the significant unmet need we are trying to address.”