China’s National Medical Products Administration Approves Naxitamab-gqgk for High-Risk Neuroblastoma

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

1. 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
2. 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