Y-mAbs confirms plans to start naxitamab filing in November – HBM-investee Y-mAbs Therapeutics (YMAB) has confirmed plans to start a rolling US filing for naxitamab for the treatment of patients its with relapsed/refractory high-risk neuroblastoma in November, after a pre-BLA meeting with the FDA. The company aims to file the clinical/safety and non-clinical portions of the rolling BLA in November and complete the CMC portion in early 2020, although Y-mAbs may be able to file this at an earlier time.
The FDA determined that the full efficacy data from the 37 patients in the currently underway multicentre “Study 201” would not be required for the BLA filing, and that its submission could be based on data from 24 patients who were treated outside Memorial Sloan-Kettering, where an earlier study had been conducted. Data from 11 patients from this group were evaluable at the time of the pre-BLA meeting and these showed an overall response rate of 73%, including 55% complete responses, which compares with 57% in the earlier MSK-conducted study.
Last week Y-mAbs confirmed the timetable for filing for omburtamab for the treatment of CNS/LM from neuroblastoma by the end of this year. Y-mAbs has a market capitalisation of $765m.