FDA Grants Fast Track Status to Annamycin for Soft Tissue Sarcoma Lung Metastases

The FDA has granted a fast track designation for annamycin as a treatment for patients with soft tissue sarcoma (STS) lung metastases, according to an announcement from Moleculin Biotech, Inc.¹

With the new status, more frequent meetings with the regulatory agency can be used to examine the development plan for annamycin and ensure that the necessary data are collected to support the approval of the agent.

The designation also allows for more frequent written communication from the FDA about proposed clinical trial designs and the utilization of biomarkers. If pertinent criteria are met, the drug could potentially be eligible for accelerated approval and priority review, or for rolling review, which means that the company can submit completed sections of its biologics license application for review by the agency.

“We are pleased to receive our second fast track designation from the FDA for annamycin. We now have potential pathways for accelerated approval in 2 indications, STS lung metastases, and the treatment of relapsed or refractory acute myeloid leukemia [AML],” Walter Klemp, chairman and chief executive officer of Moleculin Biotech, Inc., stated in a press release. “Not only does this make us eligible for accelerated approval and priority review for our NDA submission, but it serves as an important reminder of the unmet need in STS lung metastases.”

In animal models, the next-generation anthracycline has been demonstrated to accumulate in the lungs at as high as 30-fold the level of doxorubicin. The agent has also been shown to lack cardiotoxicity when examined in recent clinical trials done in patients with AML; as such, annamycin may have less limitations than doxorubicin.

The FDA recently approved the clinical-stage pharmaceutical company’s request to grant the agent Investigational New Drug status, which paved the way for the initiation of a phase 1B/2 trial for patients with STS that has lung metastases after first-line treatment.

Preclinical findings of the agent were revealed at the 2020 AACR Virtual Annual Meeting II, as well as findings from an independent laboratory announced in October 2020, which showed that annamycin is able to reach 6- to 34-fold higher levels of accumulation in the lungs compared with doxorubicin.²

In December 2020, the FDA granted an orphan drug designation to annamycin for the treatment of patients with STS.

References

1. Moleculin receives FDA approval of fast track designation for annamycin in the treatment of sarcoma lung metastases. Moleculin Biotech, Inc. March 30, 2021. Accessed March 30, 2021. https://prn.to/3rzZZ6H
2. Moleculin announces Annamycin receives FDA orphan drug designation for soft tissue sarcomas. Moleculin. News release. December 29, 2020. Accessed March 30, 2021. https://prn.to/2L3KioK