A new drug application from FDA's new base, Lenalidomide, to naldomide

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new drug(http:// (http://the sNDA application approved for use by Revlimid combined ritrusitomym (R2) for patients with previously treated follicle and marginal lymphomaThe FDA has set a target date for the Prescription Drug User Charge (PDUFA) date of June 27, 2019The study this sNDA is based on data from Phase III clinical studies The study, a randomized, double-blind, international clinical study, assessed the efficacy and safety of R2 protocols in relation to the treatment of late-stage recurrent/incurable inert lymphoma in relation to the rituximaanda-placebo program (R-placebo) A total of 358 patients with recurrent/incurable follicle lymphoma (n-295) and marginal lymphoma (n-63) were enrolled in the study 　　The results showed a statistically significant improvement in the R2 treatment group compared to the R-placebo treatment group (median PFS: 39.4 months vs 14.1 months, p 0.0001; HR 0.46 (95% CI: 0.34-0.62)) also, in terms of total lifetime (OS), the R2 treatment group showed a positive trend of improvement compared to the R-placebo treatment group (deaths: 16 cases vs 26 cases; HR s.61 (95% CI: 0.33-1.13)) The 2-year OS rate was 93% in the R2 treatment group and 87% in the R-placebo group In terms of total mitigation rate (ORR), the R2 treatment group and the R-placebo group were 78% (n?138) and 53% (n-96), respectively In terms of mitigation duration (DoR), the R2 treatment group and the R-placebo group were 33 months and 22 months, respectively (p-0.0015, HR-0.53(95% CI: 0.36-0.79)) 　　In terms of safety
the most common adverse event was neutropenocytic cell reduction (R2 treatment group vs R-placebo group: 58% vs 22%) Other common adverse events that occur in more than 20% of patients include diarrhea (31% vs 23%), constipation (26% vs 14%), cough (23% vs 17%), fatigue (22% vs 18%) Adverse events with a high rate of adverse events in the R2 treatment group included neutrophil reduction, constipation, white blood cell reduction, anemia, platelet reduction, and tumor flares No unexpected safety findings were observed in the study