CytRx rose over 12% in Thursday’s early morning trade after the biopharmaceutical research and development company said it plans to submit a rolling new drug application (NDA) to the US Food and Drug Administration for aldoxorubicin as a treatment for soft tissue sarcomas (STS).
The NDA will be under the 505(b)(2) pathway, which is designed for a new drug that contains the same active ingredient as a previously approved drug, also known as a reference drug. For aldoxorubicin, doxorubicin is the reference drug. The NDA submission is not reliant solely on the recently completed phase 3 clinical trial in STS or overall survival results. Instead, CytRx’s completed pharmacokinetic clinical trial, phase 2b and phase 3 trials in STS, along with preclinical safety and efficacy studies, will serve as “scientific bridges” between aldoxorubicin and doxorubicin. These studies, along with the published literature of doxorubicin’s effectiveness and safety, will form the basis of the NDA filing for aldoxorubicin under the 505(b)(2) regulations.