[Diary Point = Reporter Park Bo-young] The U.S. Food and Drug Administration (FDA) has accepted BeiGene’s supplemental new drug application for Brukinsa (zanubrutinib) plus rituximab as a first-line treatment for adults with mantle cell lymphoma and granted it priority review, the company said Nov. 4. The application covers adults who have not previously received treatment for the disease.
Priority review is a process that directs FDA review resources to applications that may offer a significant improvement in safety or effectiveness over existing treatments for serious conditions. The FDA aims to take action on priority review applications within six months of filing, compared with a 10-month target for standard review. The agency’s decision may be an approval or a request for additional information, among other outcomes.
The application is based on the global Phase 3 MANGROVE study. In the 510-patient trial, Brukinsa plus rituximab reduced the risk of disease progression or death by 43% compared with bendamustine plus rituximab. This was the result for the primary endpoint, progression-free survival; overall survival was also assessed as a key secondary endpoint.
Patients in the study arm took Brukinsa 160 mg twice daily and received rituximab during the initial treatment period, followed by Brukinsa alone until their disease progressed or they could no longer tolerate the drug. The comparison arm received six cycles of bendamustine and rituximab. The company said the combination’s safety profile was consistent with the known safety information for both drugs and that no new safety signals were identified.
Mantle cell lymphoma is a type of B-cell non-Hodgkin lymphoma. Brukinsa is already approved in the U.S. for adults with mantle cell lymphoma who have received prior treatment, but this application concerns first-line treatment for patients who have not yet been treated. The priority review designation does not immediately add a prescribing option for patients; the FDA review and approval process is still ongoing.
Amit Agrawal, chief medical officer of BeiGene’s hematology oncology division, said, “In newly diagnosed mantle cell lymphoma, chemoimmunotherapy remains a mainstay of first-line treatment despite its toxicity burden.” Full results from MANGROVE are scheduled to be presented Dec. 13 during a plenary scientific session at the American Society of Hematology (ASH) annual meeting.