In late March 2021, the FDA gave Fast Track designation to annamycin. The treatment, initially developed for patients with acute myeloid leukemia (AML), is now being explored for patients with soft tissue sarcoma (STS) lung metastases. According to Oncology Nursing News, this Fast Track designation followed the attribution of Orphan Drug status in December 2020.
According to Moleculin Biotech (“Moleculin”):
Annamycin is a unique next-generation liposome formulated anthracycline that has been designed to eliminate cardiotoxicity and avoid the multidrug resistance mechanisms that often defeat currently approved anthracyclines. In animal models designed to test for cardiotoxicity, Annamycin was shown to be non-cardiotoxic and in human clinical trials focused on leukemia, it showed fewer dose-limiting toxicities than are normally experienced with doxorubicin (one of the leading first-line anthracyclines).
After the FDA approved Moleculin’s Investigational New Drug (IND) application, the company was able to run a Phase 1/2 clinical trial evaluating annamycin for patients with STS lung metastases. Altogether, the preclinical data highlights that the therapy is able to accumulate 6-34x higher in the lungs than the current standard of care.
The Fast. Track designation will now allow Moleculin to have more face-time, meetings, and communication with the FDA. The FDA defines Fast Track status as:
a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
Soft Tissue Sarcoma (STS)
Soft tissue sarcoma (STS) is a rare cancer which forms in soft tissues, such as muscle, fat, blood vessels, or supporting tissue. While these tumors may form at any location throughout the body, they are often found in the abdomen, chest, arms, or legs. Because there are various types of STS, they differ in age of onset, symptoms, and affected areas. Examples of STS include:
- Synovial sarcoma
In many cases, STS tumors do not produce symptoms. Of course, once the tumor grows or the cancer spreads, symptoms may appear. Initial symptoms include:
- A noticeable lump
- Pain (if the tumor is pressing on nerves/muscles)
Symptoms may also appear depending on location. For example, an abdominal tumor could cause cramping or abdominal pain. Some people may mistake these symptoms for menstrual cramps, constipation, or indigestion. In patients with STS lung metastases, they may experience shortness of breath or difficulty breathing, as well as chest pain. Ultimately, prognosis depends on:
- The cancer stage
- Where the tumor is located