NDA for Soft Tissue Sarcoma Goes to the US FDA with Ample Evidence

The biopharmaceutical research and development company CytRx Corporation, announced an exciting new update early this month involving the company’s work with aldoxorubicin, a new drug for treatment in soft tissue sarcomas.

Soft tissue sarcoma is a cancer of more than 50 types that is highly aggressive and can arise anywhere in the body at any age.

Because of this, it is very difficult to treat, so advancements in therapy options for soft tissue sarcoma are extremely pertinent to the rare cancer community. To learn more about soft tissue sarcoma, click here.

With this in mind, it is extremely intriguing that CytRx announced that it is planning to submit a rolling New Drug Application (NDA) for aldoxorubicin for the treatment of soft tissue sarcoma under the guidelines of a reference drug.

The following were the baselines of this submission:

  • Completed Phase 2/3 trials of aldoxorubicin in soft tissue sarcomas
  • Preclinical safety and efficacy studies
  • “Scientific bridges” between aldoxorubicin and its reference drug, doxorubicin

For example, the Phase 3 clinical trial of aldoxorubicin as a monotherapy was found to be well-tolerated overall, and further, demonstrated the potential to greatly improve outcomes for relapsed or refractory soft tissue sarcoma, compared to current standard-of-cares.

To learn more about this study in particular, click here.

It sounds like there is ample evidence backing aldoxorubicin for a New Drug Application, and hopefully the FDA will agree. Stay tuned in the coming weeks and months for updates on aldoxorubicin and the status of its NDA!


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