BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma [Yahoo! Finance]
BeiGene, Ltd. - American Depositary Shares (BGNE)
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Source: Yahoo! Finance
Approval based on positive results from ROSEWOOD trial showing BRUKINSA plus obinutuzumab achieved higher overall response rate versus obinutuzumab alone BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass., March 07, 2024 BUSINESS WIRE )--BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BRUKINSA ® (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy. The indication is approved under accelerated approval based on response rate and durability of response, marking BRUKINSA's fifth indication in B-cell malignancies in the U.S. "This accelerated approval of BRUKINSA represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in
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- BeiGene Reports First Quarter 2024 Financial Results and Business UpdatesBusiness Wire
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Earnings
- 5/8/24 - Beat
BGNE
Sec Filings
- 5/8/24 - Form 10-Q
- 5/8/24 - Form 8-K
- 4/26/24 - Form ARS
- BGNE's page on the SEC website