(Reuters) -The U.S. health regulator on Thursday declined to approve a treatment from Y-mAbs Therapeutics for a rare form of nerve cancer in pediatric patients, dragging the company’s shares 16% lower in extended trading.
Y-mAbs said it is assessing the implications of the Food and Drug Administration’s complete response letter and the company’s plans for the development program for the drug, omburtamab.
The FDA’s decision follows a unanimous vote by its advisers in October against the drug to treat neuroblastoma due to insufficient evidence that it improves overall survival.
The company had asked the FDA to review data from its clinical trials that did not compare the drug to another treatment, as is the case with cancer trials traditionally.
The FDA and its advisers had raised issues over the strength of the data and uncertainty over trial results.
(Reporting by Aditya Samal and Leroy Leo in Bengaluru; Editing by Sriraj Kalluvila and Maju Samuel)
