March 30, 2021
1 min read

FDA grants fast track designation to annamycin for sarcoma lung metastases

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The FDA granted fast track designation to annamycin for the treatment of patients with lung metastases from soft tissue sarcoma, according to a press release from the agent’s manufacturer.

Approximately 20% to 50% of patients with soft tissue sarcoma develop lung metastases, complicating treatment options. Doxorubicin is used if surgery is not an option, leading to response in 10% to 30% of patients, most of whom will relapse.

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Annamycin (Moleculin Biotech) is a next-generation anthracycline that accumulates in the lungs at up to 30-fold the level of doxorubicin, according to data from animal models. The agent also did not appear associated with cardiotoxicity, a limitation of doxorubicin and other anthracyclines, in a study of patients with acute myeloid leukemia.

“We are pleased to receive our second fast track designation from the FDA for annamycin. We now have potential pathways for accelerated approval in two indications, soft tissue sarcoma lung metastases, and the treatment of relapsed or refractory acute myeloid leukemia,” Walter Klemp, Moleculin's chairman and CEO, said in the release. “This ... serves as an important reminder of the unmet need in soft tissue sarcoma lung metastases.”

An investigator-initiated clinical trial of annamycin for lung metastases from soft tissue sarcoma is expected to start later this year in Poland after receipt of a $1.5 million grant, according to the release.