Y-mAbs Therapeutics (YMAB -3.3%) announces that it expects to commence its rolling BLA submission in November for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma.
It plans to file the Clinical/Safety and non-Clinical sections first, followed by the CRC section in early 2020.
As far as efficacy is concerned, the FDA indicated that available data from the first group of 24 patients from Study 12-230 will be sufficient to support the application. In this cohort, the overall response rate was 73%, including a 55% complete response rate. Complete data from all 37 participants will be available soon.
Naxitamab is a humanized monoclonal antibody called 3F8 that targets a cancer cell surface protein called GD2.
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