FDA approves Revlimid and rituxima combination therapy for the treatment of adults with flistic lymphoma or marginal lymphoma

recently, the United StatesFDA(http://has approved Revlimid (Linamine) and rituximab combination therapy (R2) for adult stoic patients with previously treated flicosive lymphoma (FL) or marginal lymphoma (MZL)currently, applications for listing of R2 for recurrent/incurable FL and MZL are under review by the EuropeanMedicines(http://AuthorityIn addition, Shinji has submitted a supplementary application for The R2 program to treat recurrent/incurable inert B-cell NHL to Japanese regulatorsThis approval is based on positive data from Phase III research on AUGMENTThis is a randomized, double-blind, international clinical study that assesses the efficacy and safety of R2 protocols in previously treated FL and MZL patients, and compares them with placebo-litosionestudy a total of 358 patients, including FL 295 cases, MZL 63 cases, these patients received at least one system therapy, the disease relapse or difficult to treat, but not on the rituxima monoantigenThe results showed that the Non-Progression Life (PFS) in the R2 Treatment Group achieved a statistically significant improvement (median PFS: 39.4 months vs 14.1 months, HR : 0.46, 95% CI: 0.34-0.62, p 0.0001) achieved the primary endpoint of the studyData for the median follow-up of 28.3 months (range: 0.1-51.3 months) showed that in terms of total lifetime (OS), the R2 treatment group observed a positive trend of numerical improvement (HR ?0.61, 95% CI: 0.33-1.13), but did not achieve a statistically significant differenceIn terms of safety, the safety of the R2 scheme is consistent with the known safety of
the drug(http:// , and no new safety signals are found Adverse reactions reported in FL/MZL patients treated with R2 included: neutrophil reduction (58%), diarrhea (31%), constipation (26%), cough (24%), fatigue (22%), rash (22%), fever (21%), white blood cell reduction (20%), itching (20%), upper respiratory tract infection (18%), abdominal pain (18%), anemia (16%), headache (15%)