Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
The FDA has granted priority review to zanubrutinib (Brukinsa) combined with rituximab for adults with previously untreated mantle cell lymphoma (MCL). The application is backed by phase 3 MANGROVE trial data showing the combo cut the risk of disease progression or death by 43% compared to standard chemoimmunotherapy. This could mark a significant shift toward chemotherapy-free frontline treatment for MCL.
The FDA has granted priority review to a supplemental new drug application (sNDA) for zanubrutinib (Brukinsa) plus rituximab (Rituxan) as a frontline treatment for adults with previously untreated mantle cell lymphoma (MCL). Priority review shortens the FDA's standard evaluation timeline, signaling the agency's recognition of the regimen's potential to address an unmet medical need.
The application is supported by data from the global, randomized phase 3 MANGROVE trial, which enrolled 510 patients with previously untreated MCL who were ineligible for stem cell transplantation. The trial showed that zanubrutinib plus rituximab significantly outperformed the standard bendamustine plus rituximab (BR) regimen, with full efficacy results set to be presented at the ASH Annual Meeting in December 2026. Regulatory submissions have also been accepted in Europe and China.
By the Numbers
Why it matters: Chemoimmunotherapy has long been the standard for frontline MCL despite its toxicity burden. A chemotherapy-free regimen that meaningfully reduces disease progression could reshape treatment for older or less fit patients who are most vulnerable to chemo-related side effects.
