FDA updates medication regimen for chronic lymphocytic leukemia

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The US Food and Drug Administration approved Venetoclax (Venclexta) combined with rituximab (VenR) for the treatment of patients with chronic lymphocytic leukemia (CLL) based on the minimal residual disease (MRD) data of the phase III MURANO trial, and the efficacy is significantly better In combination with bendamustine and rituximab (BR) regimen.

The MURANO study found that the efficacy of chemoimmunotherapy for CLL is related to the possibility of achieving MRD conversion, and whether the efficacy of targeted drug treatment for refractory or relapsed CLL is related to MRD conversion, because the rate of MRD conversion in these patients is relatively unknown. low.

The MURANO study showed that VenR regimen had better PFS for refractory or relapsed CLL compared with BR regimen (HR0.17), and the MRD of peripheral blood and bone marrow turned negative. The conversion of MRD to negative in the VenR group was not related to whether the patient had del (17p), non-IGVH mutation, TP53 mutation and other adverse prognostic factors. In the VenR group, 121/194 patients (62%) had MRD negative at the end of the combination therapy. At a median follow-up of 13.8 months (5.6-23.0 months), 100 patients (83%) still had negative MRD and 2 patients Progression to PD, 2 cases died of irrelevant disease, 2 cases progressed to Richter’s syndrome, 15 cases (12%) MRD turned positive [1 case MRD≥10 ^ (-2) and PD, 14 cases MRD 10 ^ (-4) ~ <10 ^ (-2) and 2 of them were PD, 1 died, and 11 still had no progress.

VenR treatment of refractory or relapsed CLL has a high degree of consistency in obtaining peripheral blood and bone marrow MRD conversion, and the status of peripheral blood MRD is significantly related to clinical efficacy. VenR can enable patients to obtain deep and durable high peripheral blood MRD conversion rate at an early stage, and has nothing to do with whether patients have adverse prognostic factors, which is significantly better than the BR program. The recurrence of MRD is only seen in a few patients and may not necessarily lead to clinical disease progression. It is suggested that VenR’s efficacy is significantly better than BR regimen, and it is currently a recommended regimen for refractory or relapsed CLL.

https://www.onclive.com/web-exclusives/fda-updates-venetoclax-cll-label-with-mrd-data

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