MedPacto's anti-cancer substance designated as US FDA fast-track item

South Korean biotech company MedPacto Inc. ’s Vactosertib monotherapy for osteosarcoma patients has been designated as a fast-track development item by the US Food and Drug Administration.

"Following last year's rare pediatric disease designation (RPDD), the latest fast-track designation is expected to accelerate the development of Vactosertib as a treatment for osteosarcoma in the future," a MedPacto official said on Tuesday.

Fast-track designation is one of the new drug development facilitation processes undertaken by the FDA for the purpose of early supply of new drugs to patients in critical areas such as treatment for severe health conditions.

Eligible medicines include new drugs intended to treat or prevent diseases for which there is no existing treatment, as well as medicines that demonstrate improvement over existing treatments if there are such treatments.

Fast-track-designated new drugs can receive various support from the FDA at each stage of development. In close consultation with the FDA, the drug development process can proceed more expeditiously than usual.

In addition, the benefit of "rolling review" (sequential submission and review as soon as data are available when applying for marketing approval) is granted, and a "priority review" (which reduces the FDA review period to six months when applying for marketing approval) can be negotiated with the FDA.

MedPacto expects that it will be able to work more closely with FDA officials in the process of developing Vactosertib, which will allow for more rapid approval and market launch as a treatment for osteosarcoma.

Write to Jae-Young Han at yhan@hankyung.com