Efficacy of Naxitamab Injection (Naxitamab)

Efficacy was evaluated in patients with relapsed or refractory neuroblastoma in bone or bone marrow who participated in two single-arm, open-label trials: Study 201 and Study 12-230. Patients with disease progression after the most recent treatment were excluded.

On days 1, 3, and 5 of each 4-week cycle, patients received 3 mg/kg Naxitamab intravenously as an intravenous infusion, and GM-CSF was injected subcutaneously at 250 g/m2/day and 500 g/m2/day on days 4-0 and 1-5, respectively. Patients were allowed to receive preplanned radiation therapy to the site of primary disease in Study 201 and to non-target bone lesions or soft tissue disease in Study 12-230, at the discretion of the investigators. The primary efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) according to the revised International Neuroblastoma Response Criteria (INRC). Among 22 patients treated in multicenter study 201, the ORR was 45%, and 30% of responders had a DOR greater than or equal to 6 months. Among the 38 patients treated in single-center study 12-230, the ORR was 34%, with 23% having a DOR greater than or equal to 6 months. For both trials, responses were observed in bone, marrow, or both.

It is understood that noxituzumab injection has been approved in China, but it has not been included in medical insurance. Its price is still unclear and the purchase method is difficult. The original drug of Naxituzumab injection marketed overseas is very expensive, and the price may fluctuate due to exchange rates. For more drug information and specific prices, please consult a medical consultant.