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NEWS

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

Shots: The US FDA has accepted NDA & granted priority review to sonrotoclax for adults with r/r mantle cell lymphoma following treatment with a BTK inhibitor   NDA was supported by the global P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts (n=125), which met its 1EP of improved ORR per IRC, with benefits seen across…
November 26, 2025

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NEWS

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 therapy Decision 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…
October 13, 2025

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Galapagos
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 MCL Trial demonstrated superior ORR & CR rate as well as favorable safety…
August 6, 2025

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Johnson& Johnson
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 ASCT Approval was based on ongoing P-III (TRIANGLE) trial in 870 EU pts, assessing ibrutinib + chemoimmunotherapy (CIT) ± ASCT & 2yr. ibrutinib…
July 23, 2025

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Astrazeneca
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…
January 20, 2025

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Top Performing Drug of 2021 – Imbruvica (January Edition)
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 Analysis Imbruvica is an oral therapy that inhibits a protein called Bruton's tyrosine kinase. Imbruvica was one…
January 25, 2023

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