FDA grants fast track designation to annamycin for sarcoma lung metastases

The U.S. Food and Drug Administration has granted fast track designation for Annamycin (Moleculin Biotech, Inc), for the treatment of soft tissue sarcoma (STS) lung metastases, according to a press release.

“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, STS lung metastases, and the treatment of relapsed or refractory acute myeloid leukemia,” said Walter Klemp, Moleculin’s Chairman and CEO, 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. We are now focused on initiating our internally funded clinical trial in the US, possibly prior to mid-year. In addition, we recently announced a $1.5 million grant awarded in Poland for an investigator-initiated clinical trial there for this indication which should start later this year.”

Read the full press release here.