Why is Obinutuzumab not recommended?

The first anti-CD20 monoclonal antibody rituximab has significantly improved the prognosis of patients with B-cell lymphoproliferative diseases. Obinutuzumab was developed to enhance activity and overcome resistance to rituximab. Clinical data suggest that otuzumab is superior to rituximab in follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL), however it increases toxicity.

All randomized controlled trials in clinical studies compared otuzumab-based regimens with rituximab-based regimens to better assess their toxicity profiles, with the primary outcome being grade 3-4 infections Secondary outcomes included any adverse events (AE), grade 3-4 AEs, discontinuation rates, and 3-year mortality in patients with FL, CLL, and diffuse large B-cell lymphoma. The monoclonal antibodies were administered with different chemotherapy regimens (in four trials) or as monotherapy (in one trial). Point estimates favored an increase in the rate of grade 3-4 infections (RR1.17) and the rate of any AEs (RR1.05) in the otuzumab group, although this was not statistically significant. There was a significant increase in the incidence of grade 3-4 AEs (RR1.15) and grade 3-4 toxicities, including thrombocytopenia (RR2.8), infusion-related reactions (RR2.8), and cardiac events (RR1.65). There were no significant differences in grade 3-4 anemia and neutropenia, and there was no significant difference in 3-year mortality. The point estimate favored an increased rate of discontinuation due to adverse events with otuzumab.

The original drug of Otuzumab has been launched in China and has entered the scope of medical insurance, but it is only reimbursed for patients who meet the indications. Specifications The price of 1000mg (40ml)*1 bottle may be around 9,000 yuan, which is a strictly controlled drug. The price of the Turkish version of Otuzumab Specifications1000mg/40ml per box listed overseas may be around RMB 10,000 (the price may fluctuate due to the exchange rate). The ingredients of the original drugs sold domestically and abroad are basically the same. There is currently no generic version of Otuzumab produced and launched. For more drug information and specific prices, please consult the medical consultant of Yaode.