BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

Shots:The US FDA has granted BTD to sonrotoclax for adults with r/r MCL & accepted BeOne’s request for participation in Project Orbis for concurrent global review of the therapyDecision was based on P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on…

ByRidhi RastogiOctober 13, 2025

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BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)

Shots:The P-I/II (BGB-11417-201) trial of sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on sonrotoclax (160 or 320mg, QD), while Part 2 enrolled 103 pts on 320mg QD after ramp-upTrial met its 1EP of improved ORR per IRC & showed significant improvements across 2EPs,…

ByRidhi RastogiAugust 29, 2025

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BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Shots:The EC has approved neoadj. Tevimbra + Pt-based CT followed by adj. Tevimbra monotx. for adults with resectable NSCLC at high risk of recurrenceApproval was based on P-III (RATIONALE-315) trial assessing perioperative Tevimbra with CT before surgery vs PBO + CT in NSCLC pts (n=453), which met its dual 1EPs of EFS &…

ByRidhi RastogiAugust 27, 2025

NEWS

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

Shots:The US FDA has approved IND application of ABT-301 to initiate P-I/II trial for pts with metastatic colorectal cancer (mCRC)Trial will assess ABT-301 + Tevimbra (provided by Beone) + Avastin in ~66 pts across Taiwan & Australia, with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRCAdditionally, Anbogen is pursuing global licensing,…

ByRidhi RastogiAugust 4, 2025

BeOne Medicines’ Sonrotoclax Receives FDA’s Breakthrough Therapy Designation for R/R Mantle Cell Lymphoma (MCL)

BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)

BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

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