Rixathon (rituximab biosimilar)

Real-world, multicenter, open-label, single-arm, non-interventional, post-approval study of SDZ-RTX in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with treatment-naïve CD20‑positive DLBCL. This real-world, 2-year study reconfirms that first-line treatment of CD20-positive DLBCL with R-CHOP using SDZ-RTX is effective and well tolerated. N/A.

This study reconfirms that 1st line treatment of CD20+ DLBCL with R-CHOP using SDZ-RTX (Rixathon [c]) is effective over a 24-months observation period with no unexpected safety signals.

Most rapid infusions of SDZ-RTX were in combination with CHOP/CHOP-like therapy (48.4%), followed by SDZ-RTX alone (15.1%), in combination with bendamustine (14.5%), or with other regimens (22%). The incidence of any grade IRR during the first rapid infusion was 1% (five grade 1 IRRs and one grade 2 IRR). In conclusion, rapid 90-minute IV administration of SDZ-RTX for the second and subsequent infusions during the course of therapy is well tolerated in patients with CD20+ lymphoma or CLL.

REFLECT is a real-world, multicenter , open-label, single-arm, non-interventional trial , and is the first prospective , post-approval study of SDZ-RTX in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone ( R- CHOP ) as a curative therapy for patients with CD20 ‑ positive diffuse large B-cell lymphoma (DLBCL). Conclusion This real-world , post-approval study reconfirms that first - line treatment of CD20 -positive DLBCL with R-CHOP using SDZ-RTX is effective over a 24-month observation period , with no unexpected safety signals. These data may help to broaden patient access to rituximab-based chemotherapy and support the sustainability of cancer care .