European Commission (EC) grants approval to Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of adult patients with R/R, BTK inhibitor-treated MCL December 2, 2025
Positive Topline Results for Sonrotoclax in R/R MCL Announced; primary endpoint of ORR met September 3, 2025
First patient dosed in registrational clinical trial of mesutoclax for the treatment of BTKi-experienced mantle cell lymphoma in China August 26, 2025
IMBRUVICA® (ibrutinib) receives positive CHMP opinion for the treatment of 1L MCL patients eligible for autologous stem cell transplant July 1, 2025
BORUZU, First Ready-to-Use Bortezomib Injection for Multiple Myeloma and Mantle Cell Lymphoma, launched April 8, 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP for 1L MCL April 2, 2025
Calquence plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma January 21, 2025
Type II variation application submitted to the EMA seeking approval of IMBRUVICA in adult patients with 1L MCL eligible for auto SCT December 25, 2024
Calquence granted Priority Review in the US for patients with untreated mantle cell lymphoma October 8, 2024
FDA approves BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous administration or IV administration September 10, 2024
NMPA approves Supplemental BLA for Carteyva® in Adult Patients with R/R Mantle Cell Lymphoma September 3, 2024
Calquence + chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. SOC in patients with untreated mantle cell lymphoma in ECHO Ph 3 trial June 18, 2024
Calquence combo regimen demonstrated statistically significant and clinically meaningful PFS improvement in 1L MCL in ECHO Ph 3 trial May 7, 2024
Regulatory Applications Accepted in the U.S. and Japan for Breyanzi (lisocabtagene maraleucel) in R/R Follicular Lymphoma and R/R Mantle Cell Lymphoma February 26, 2024
ICML 2023: Breyanzi (lisocabtagene maraleucel) Delivers Deep and Durable Responses in R/R FL and MCL in TRANSCEND Clinical Trials June 28, 2023
TRANSCEND FL and TRANSCEND NHL 001 Studies of Breyanzi in R/R FL and MCL Meet Primary Endpoint of ORR May 10, 2023
IMBRUVICA’s U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications to be voluntarily withdrawn April 12, 2023
