MedPacto's 'Bactosertib' Designated as FDA Fast Track

[Photo by MedPacto]

[Asia Economy Reporter Chunhee Lee] MedPacto announced on the 17th that its single-agent therapy Vactosertib for osteosarcoma patients has been designated as a Fast Track development product by the U.S. Food and Drug Administration (FDA).

Fast Track is one of the FDA's drug development acceleration procedures implemented to provide early access to major new drugs, such as treatments for serious diseases. It applies to new drugs aimed at treating or preventing diseases with no existing treatments, as well as drugs that demonstrate improvements over existing therapies.

Once designated as Fast Track, developers can receive various supports from the FDA at each development stage, enabling faster new drug development. Additionally, the 'Rolling Review' benefit allows submitting data sequentially for review as it becomes available before the complete data package is ready for marketing approval. There is also the possibility of negotiating 'Priority Review,' which shortens the review period to six months.

MedPacto expects that closer collaboration with FDA officials during the development of Vactosertib will accelerate the approval and launch of the drug as a treatment for osteosarcoma.

Timothy Allen, Vice President of MedPacto Therapeutics, said, "We have gained an opportunity to be a 'game changer.' It is highly meaningful that we can save patients fighting the malignancy of metastatic osteosarcoma with an orally administered single-agent therapy, Vactosertib."

Osteosarcoma is a malignant tumor originating in bone or bone-related cartilage and other osseous tissues. It is one of the representative pediatric cancers with a high incidence in children and adolescents. Moreover, 25-50% of patients experience metastasis to the lungs, brain, and other organs during chemotherapy, which can lead to death.

A MedPacto official stated, "Following last year's designation as a Rare Pediatric Disease Drug (RPDD), the Fast Track designation is expected to further accelerate the development of Vactosertib as a treatment for osteosarcoma."

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