It is the first FDA-approval the company has received and the approval has been given in an accelerated assessment on the drug Naxitamab as it addresses diseases where there are few treatment options. Therefore, Y-mAbs is also required to continue the clinical trials after the approval of the drug.
The drug Naxitamab, which is now called DANYELZA, is a drug used to treat neuroblastoma, cancer that occurs in the nervous system of primary infants and young children. Therefore, the drug has been approved for children over one year and can also be used for adults.
The approval has a special significance for founder and chairman Thomas Gad: “It is very exciting to see how this treatment has gone from being an experimental therapy used at my daughter’s bed to now being approved by the FDA. On behalf of Y-mAbs, I would like to thank all the patients and physicians who participated in our clinical trials and our scientific partner, Memorial Sloan Kettering, for helping us achieve this goal.”
The approval of DANYELZA represents an important step in working towards the company’s mission to become a world leader in the development of better and safer antibody-based oncology products that meet unmet pediatric and adult medical needs.
Read more about the news on Y-mAbs website here.