China’s National Medical Products Administration Approves Naxitamab-gqgk for High-Risk Neuroblastoma
Patients in China diagnosed with high-risk neuroblastoma can now receive treatment with naxitamab-gqgk, which was recently given the greenlight by the National Medical Products Administration.
China’s National Medical Products Administration has granted approval to naxitamab-gqgk (Danyelza) to treat patients with high-risk neuroblastoma, according to a press release from Y-mAbs Therapeutics.1
Naxitamab is a humanized monoclonal antibody targeting GD2, a ganglioside known to be highly expressed in sarcomas and neuroectoderm-derived tumors. The agent was approved at a dose of 40 mg/10 mL and is administered 3 times weekly in the outpatient setting for 4 weeks.
Patients aged 1 year or older with relapsed/refractory, high-risk neuroblastoma of the bone or bone marrow are able to receive naxitamab in conjunction with granulocyte macrophage colony stimulating factor (GM-CSF) if they have achieved a partial response, minor response, or stable disease following previous therapy.
Notably, maintaining approval for the agent may be dependent on findings from the phase 2 Study 201, evaluating naxitamab in a population diagnosed with high-risk neuroblastoma who have either primary refractory disease or an incomplete response to salvage treatment for bone and/or bone marrow. At least 10 patients will need to be enrolled in China.
A combination of naxitamab and GM-CSF received accelerated approval from the FDA In November 2020 for patients aged 1 year or older with relapsed/refractory high-risk neuroblastoma of the bone or bone marrow who had partial response, minor response, or stable disease after previous therapy.2
Much like the Chinese approval, the United States accelerated approval of naxitamab is dependent on additional results from Study 201.
References
- Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the treatment of high-risk neuroblastoma approved in China. News release. Y-mAbs Therapeutics. December 8, 2022. Accessed December 9, 2022. https://bit.ly/3Bml3We
- FDA approves Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the treatment of neuroblastoma. News release. Y-mAbs Therapeutics. November 25, 2020. Accessed December 9, 2022. https://bit.ly/3FfmYgm
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