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U.S. FDA Grants Priority Review to BeOne Medicines’ BRUKINSA Combination in First-Line Mantle Cell Lymphoma

Wednesday, November 4, 2026 BiopharmaWatch Research 1 min read
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Key Takeaway: BeOne Medicines announced that the FDA has granted Priority Review for its supplemental New Drug Application for BRUKINSA in combination with rituximab. This application is aimed at treating adult patients with previously untreated mantle cell lymphoma. The decision is based on data from the pivotal Phase 3 MANGROVE trial.

Market Sentiment Analysis

POSITIVE FACTORS

  • FDA granted Priority Review status
  • Application supported by pivotal Phase 3 data
  • Targets previously untreated mantle cell lymphoma

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+45%
120-day peak, hindsight
Typical move
2.8%
average across 15 past catalysts
Lead asset
BGB-43395
Phase 1 · Advanced Solid Tumor

Full Press Release Details

SAN CARLOS, Calif.--(BUSINESS WIRE)---- $ONC #BeOne--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for BRUKINSA® (zanubrutinib) in combination with rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The application is supported by data from the pivotal Phase 3 MANGROVE

Frequently Asked Questions

What is BRUKINSA used for?

BRUKINSA is used for treating mantle cell lymphoma.

What did the FDA grant to BeOne Medicines?

The FDA granted Priority Review for BRUKINSA's sNDA.

What data supports the BRUKINSA application?

The application is supported by data from the Phase 3 MANGROVE trial.

Who are the patients targeted by BRUKINSA?

BRUKINSA targets adult patients with previously untreated mantle cell lymphoma.

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Tags: ONC BeOne Medicines BRUKINSA mantle cell lymphoma FDA Priority Review
Last updated: Nov 4, 2026

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Lead asset
BGB-43395Phase 1
Advanced Solid Tumor →

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