FDA Grants Priority Review to Revlimid Plus Rituxan for Indolent Non-Hodgkin Lymphoma

The Food and Drug Administration (FDA) granted a priority review to Revlimid (lenalidomide) plus Rituxan (rituximab) for the treatment of patients with previously treated follicular lymphoma and marginal zone lymphoma.

The supplemental new drug application is based on the phase 3 AUGMENT trial, in which the combination regimen reduced the risk of disease progression or death by 54 percent compared with Rituxan alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma.

The double-blind trial included 358 patients with relapsed/refractory follicular lymphoma (295 patients) or marginal zone lymphoma (63 patients) in need of treatment. Patients had to have received at least one prior chemotherapy, immunotherapy or chemoimmunotherapy regimen, and could not be Rituxan refractory.

At a median follow-up of 28.3 months, the median progression-free survival — or time to disease progression or worsening – per independent review was 39.4 months with the combination versus 14.1 months with Rituxan alone. By investigator assessment, the median progression-free survival was 25.3 months versus 14.3 months, respectively.

Overall response rate was also significantly improved with the combination, which by independent review was 78 percent in the combination arm, with a 44 percent complete response rate and a 34 percent partial response rate.

Thirty percent of patients in the combination arm discontinued treatment early compared with 39 percent of patients in the placebo arm. The primary cause of discontinuation was disease progression, at 12 percent in the combination arm versus 30 percent in the control arm. Side effects led to discontinuation in 8 percent of the combination group versus 4 percent of the placebo group. Among patients receiving Revlimid, 66 percent had at least one side effect-related dose interruption.

“(Revlimid plus Rituxan) has the potential to offer patients with previously treated follicular lymphoma and marginal zone lymphoma a chemotherapy-free option” Jay Backstrom, M.D., chief medical officer and head of Global Regulatory Affairs for Celgene, the manufacturer of Revlimid, said in a statement . “We look forward to working with the FDA to bring the R2 regimen to patients as quickly as possible.”

The FDA is scheduled to make a decision by June 27, 2019.

This article originally appeared on OncLive, as “FDA Grants Lenalidomide/Rituximab Priority Review for Indolent Non-Hodgkin Lymphoma.”