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

NEWS

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

NEWS

Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

Shots:The US FDA has granted RMAT designation to GLPG5101 for the r/r mantle cell lymphoma (MCL)Designation was supported by P-I/II (ATALANTA-1) trial assessing GLPG5101 [50×106 (DL1), 110×106 (DL2) & 250×106 (DL3)] in r/r B-cell Non-Hodgkin Lymphoma pts, incl. those with MCLTrial demonstrated superior ORR & CR rate as well as favorable safety…

ByRidhi RastogiAugust 6, 2025

NEWS

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

Shots:The EC has approved a label extension for Imbruvica (ibrutinib) + R-CHOP alternating with R-DHAP (without ibrutinib), followed by ibrutinib monotx., for the treatment of previously untreated MCL pts ineligible for ASCTApproval was based on ongoing P-III (TRIANGLE) trial in 870 EU pts, assessing ibrutinib + chemoimmunotherapy (CIT) ± ASCT & 2yr. ibrutinib…

ByRidhi RastogiJuly 23, 2025

NEWS

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

Shots:The US FDA has approved Calquence + bendamustine & rituximab for untreated MCL in patients not for autologous HSCT, also transforming its accelerated approval (Oct 2017) to full approval for previously treated MCL. The combination is under review in Australia, Canada, Switzerland, the EU, Japan & other regions Approval was based on P-III…

ByRidhi RastogiJanuary 20, 2025

INSIGHTS+

Top Performing Drug of 2021 – Imbruvica (January Edition)

Active Ingredient: Ibrutinib Dosage Forms & Strengths: Capsules: 70 mg and 140 mg Tablets: 140 mg, 280 mg, 420 mg, and 560 mg Mechanism of Action: Bruton's tyrosine kinase Inhibitor (BTKi) First Approval: US (13 Nov 2013), EU (Oct 2014)  Revenue AnalysisImbruvica is an oral therapy that inhibits a protein called Bruton's tyrosine kinase. Imbruvica was one…

BySenior EditorJanuary 25, 2023

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)

Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

Johnson & Johnson’s Imbruvica Receives the EC’s Approval for Previously Untreated Mantle Cell Lymphoma (MCL)

AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the US FDA’s Approval for Mantle Cell Lymphoma (MCL)

Top Performing Drug of 2021 – Imbruvica (January Edition)

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