The Food and Drug Administration (FDA) has approved Rituxan (rituximab) in combination with chemotherapy for the treatment of patients 6 months of age and older with previously untreated, advanced stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). 

The approval was based on data from the open-label, randomized phase 3 Inter-B-NHL Ritux 2010 trial (ClinicalTrials.gov Identifier: NCT01516580), which evaluated the efficacy and safety of rituximab in combination with chemotherapy in 362 patients 6 months of age and older with previously untreated, advanced stage, CD20-positive, DLBCL, BL, BLL, and B-AL. 

Patients were randomly assigned to receive Lymphome Malin B (LMB) chemotherapy (corticosteroids, vincristine, cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, and triple drug [methotrexate/cytarabine/corticosteroid] intrathecal therapy) alone (n=164) or in combination with rituximab (n=164).

The primary endpoint was event-free survival (EFS); an event was defined as occurrence of progressive disease, relapse, second malignancy, death from any cause, or nonresponse as evidenced by detection of viable cells in residue after the second cytarabine/etoposide course.


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Interim analysis showed that after a median follow-up of 3.1 years, there were 28 events in the LMB chemotherapy arm and 10 events in the rituximab plus LMB arm (hazard ratio 0.32; 90% CI, 0.17-0.58; P =.0012). As of data cutoff date on December 31, 2017, there were 20 deaths reported in the LMB arm and 8 deaths in the rituximab plus LMB arm, with an estimated overall survival (OS) hazard ratio of 0.36 (95% CI, 0.16-0.81). The OS result is considered descriptive because a formal statistical test was not conducted for OS.

The most common adverse reactions of grade 3 or higher for rituximab plus LMB chemotherapy were febrile neutropenia, stomatitis, enteritis, sepsis, increased alanine aminotransferase, and hypokalemia.

References

  1. FDA approves rituximab plus chemotherapy for pediatric cancer indications. News release. December 3, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-rituximab-plus-chemotherapy-pediatric-cancer-indications. 
  2. Rituxan. Package insert. Genentech; 2021. December 3, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf.

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