All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.

  TRANSLATE

The lym Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the lym Hub cannot guarantee the accuracy of translated content. The lym and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

The Lymphoma & CLL Hub is an independent medical education platform, sponsored by AbbVie, BeOne Medicines, Johnson & Johnson, Roche, and Sobi, and supported through educational grants from Bristol Myers Squibb, Incyte, Lilly, and Pfizer.   View funders.

Now you can support HCPs in making informed decisions for their patients

Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.

Find out more

FDA grants priority review to lenalidomide and rituximab combination for the treatment of indolent NHL

Feb 28, 2019


On 26 February 2019, the US Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) and granted priority review to the lenalidomide and rituximab (R2) regimen, for the treatment of patients with previously treated relapsed/refractory (R/R) follicular lymphoma (FL) and marginal zone lymphoma (MZL).

The sNDA for the R2 regimen was based on the results from the multicenter, randomized, double-blind, phase III AUGMENT (NCT01938001) trial, which assessed the efficacy of the R2 regimen compared to single-agent rituximab therapy in patients with R/R FL or MZL. The results from this trial showed that according to independent review committee, progression-free survival in patients in the R2 arm was 39.4 months (95% CI, 22.9–not evaluable) compared to 14.1 months (95% CI, 11.4–16.7) in patients receiving rituximab monotherapy, with a median follow-up of 28.3 months. Further results from the AUGMENT study were presented at the 60th Annual Meeting of the American Society of Hematology (ASH), read more here.

According to the drug manufacturers, the R2 regimen “has the potential to offer patients with previously treated follicular lymphoma and marginal zone lymphoma a chemotherapy-free option”.

References

Your opinion matters

Which of the following would most increase your confidence in referring patients with R/R large B-cell lymphoma for CAR T-cell therapy?