MedPacto receives U.S. FDA Fast Track designation for vactosertib for the treatment of metastatic osteosarcoma
Jan 17, 2023
Can significantly shorten the drug product launch into the marketIND approval for a phase1/2 clinical trial was granted in August 2022
On January 17, 2023, MedPacto, a genome-based drug discovery and clinical-stage biotechnology company, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to vactosertib as a monotherapy treatment for relapsed/refractory metastatic osteosarcoma.
The FDA’s Fast Track designation is designed to facilitate the development and review of drugs to treat serious conditions and address an unmet need. By speeding up these processes, new drugs can get to patients faster than they normally would. Any drug candidate being developed to treat or prevent a condition with no current therapy is directed at an unmet need. If there are available therapies, the drug candidate must show a significant advantage over the current available therapy to qualify as such by having a differentiating benefit-risk ratio.
A drug candidate that receives the FDA’s Fast Track designation is provided with extensive support from the FDA at each stage of development and, it is eligible for rolling review.
Rolling review allows a drug company to submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. The BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA. This significantly shortens the time to launch the drug product into the market.
In addition, a drug that receives Fast Track designation is eligible for Priority Review, if relevant criteria are met.
Timothy R. Allen, MD, Ph.D., Executive Vice President of MedPacto Therapeutics, stated “We are offered the opportunity to be a game changer. An oral monotherapy medication to be a life saver to fight the evil of metastatic osteosarcoma is a huge opportunity. I am very encouraged and motivated, scientifically, and clinically. This is offering the patients the much-needed chance.”
MedPacto received IND approval for a phase1/2 clinical metastatic osteosarcoma trial in August 2022.