Shots:Genmab has reported P-III (EPCORE FL-1) trial data assessing epcoritamab (SC) + rituximab & lenalidomide (R2) vs R2 alone for the treatment of adult patients with r/r follicular lymphomaThe trial met dual primary endpoints with improved ORR and PFS, reducing risk of progression or death by 79%; interim data will be submitted to…
Shots:The US FDA has approved Monjuvi (tafasitamab-cxix) + rituximab & lenalidomide for the treatment of adult pts with r/r follicular lymphoma (FL)Approval was based on the P-III (inMIND) trial assessing Monjuvi regimen vs PBO + rituximab & lenalidomide in adults (n=654) with r/r Grade 1 to 3a FL or r/r nodal, splenic or…
Shots:The EC has approved Calquence + bendamustine & rituximab for the treatment of ASCT-ineligible pts with previously untreated MCL; regulatory review is ongoing in Japan & other regionsApproval was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed improved PFS of 27%,…
Shots:The CHMP has recommended Calquence + bendamustine & rituximab for the treatment of 1L MCL adults, who are ineligible for autologous HSCT; regulatory review is ongoing in Japan & other regionsOpinion was based on P-III (ECHO) trial assessing the combination vs SoC (bendamustine & rituximab) in 1L MCL pts (≥65yrs.; n=635), which showed…
Shots:The patient enrollment in confirmatory P-III (LOTIS-5) study assessing Zynlonta + rituximab for treating 2L+ r/r DLBCL has been completed. Zynlonta was previously approved in 2021 under accelerated pathway for the same
The study aims to convert accelerated approval & support label expansion to 2L+ with rituximab. Part 1 enrolled 20 patients for…
Shots: The CHMP has granted a positive opinion to DRL_RI (Ituxredi), a biosimilar of MabThera (rituximab) The approval, if granted, would be applicable across the whole EU plus Norway, Iceland & Liechtenstein. A separate MAA will be submitted to the MHRA as per reliance route under the IRP Ituxredi (CD20 directed cytolytic Ab) is for the…

