Y-mAbs Therapeutics confirmed BLAs on track for this year – HBM Healthcare-portfolio company Y-mAbs Therapeutics (Nasdaq: YMAB) has confirmed it remains on target to file regulatory submissions for both of its rare paediatric cancer products this year.
The company confirmed it is on track to file for omburtamab for the treatment of CNS/LM from neuroblastoma, having just met the target recruitment of 18 patients in its study in this ultra-rare condition.The study will continue to enroll patients until the product potentially becomes available on the market. The company holds breakthrough therapy designation, orphan drug designation and rare pediatric disease designation (“RPDD”) for omburtamab from the FDA for CNS/LM from neuroblastoma and thus qualifies for receipt of a priority review voucher, if the product is approved.
The company also stated that it has recruited more than 30 patients of a planned 37 in a study of naxitamab for relapsed/refractory high-risk neuroblastoma and hopes that the remaining patients to be added in the coming weeks. It expects to meet the target for a BLA filing in 2019 for use in combination with GM-CSF for the treatment of relapsed/refractory high-risk neuroblastoma.
The company expects both products to reach the market in 2020.