News and Press Releases
Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma
Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 23, 2025
New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma
Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV IRAKLIA is...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025
ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients
New analysis from the IMROZ phase 3 study of Sarclisa-VRd demonstrated higher and sustained MRD negativity rates in transplant-ineligible NDMM patients versus VRd alone New detailed results from the GMMG-HD7...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 9, 2024
DARZALEX® (daratumumab) subcutaneous formulation shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smouldering multiple myeloma
First subcutaneous anti-CD38 therapy to demonstrate potential to prevent end-organ damage, and extendprogression-free survival and overall survival based on findings from Phase 3 AQUILA study 8 December 2024 – BEERSE,...
Category: Clinical Trials
Posted: December 9, 2024
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CARVYKTI® ▼ (ciltacabtagene autoleucel; cilta-cel) is the first cell therapy to significantly extend overall survival versus standard therapies for patients with multiple myeloma as early as second line
45 percent reduction in risk of death achieved with cilta-cel versus standard therapies after threeyear follow-up in landmark CARTITUDE-4 study Data featured in a late-breaking oral presentation at the 2024...
Category:
Posted: October 1, 2024
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DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
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TALVEY (talquetamab) demonstrated highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma
24-month overall survival rate of 67% achieved with talquetamab 0.8mg/kg biweekly dosing in the phase 1/2 MonumenTAL-1 study 14 June 2024 – Beerse, Belgium – Janssen-Cilag International NV, a Johnson...
Category: Biotechnology, Drug Discovery
Posted: June 17, 2024
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CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) significantly improved progression-free survival and deepened responses versus two standard therapies for patients with functional high-risk multiple myeloma
73% reduction in risk of disease progression or death seen with cilta-cel in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy...
Category: Biotechnology, Clinical Trials, Drug Discovery
Posted: June 4, 2024
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TECVAYLI▼ (teclistamab) shows sustained deep and durable responses in patients with relapsed or refractory multiple myeloma
New MajesTEC-1 data show a median duration of response of 24 months, with responses deepening, including in patients who switched to biweekly dosing Separate analyses from the MajesTEC-1 and OPTec...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 3, 2024
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DARZALEX (daratumumab)-based regimens significantly improved clinical outcomes in both transplant-eligible and -ineligible patients who are newly diagnosed with multiple myeloma
88% of transplant-eligible patients achieved a complete response or better, and 47% of patients sustained MRD-negativity for longer than one year with daratumumab subcutaneous formulation-based regimens in the phase 3...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 3, 2024
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KITE Shares New Data at EHA 2024 Which Demonstrates Positive Patient Outcomes and Advances in Delivery of CAR T-Cell Therapy
Analysis comparing real-world and clinical trial data shows Yescarta (Axicabtagene Ciloleucel) has higher manufacturing success rates and improved T-cell performance, respectively, in second-line vs third-line+ treatment of large B-cell lymphoma...
Category: Clinical Trials, Pharmaceutical
Posted: May 14, 2024
CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the EC for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse Approval is based on results from...
Category: Biotechnology, Clinical Trials
Posted: April 22, 2024
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Over a thousand people with multiple myeloma may be eligible for treatment with Nexpovio▼ (selinexor) following NICE recommendation addressing ‘significant unmet need’ for this incurable blood cancer
NEXPOVIO has been recommended for use in the NHS, offering the opportunity to improve patient outcomes in this challenging and complex cancer NEXPOVIO has the potential to address significant treatment...
Category: Biotechnology, Pharmaceutical
Posted: April 22, 2024
DARZALEX (daratumumab) Subcutaneous Formulation-based Quadruplet Therapy Regimen Shows Significant Improvement in Outcomes for Patients with Transplant-eligible Newly Diagnosed Multiple Myeloma
Daratumumab subcutaneous-based induction, consolidation and maintenance regimen reduced risk of progression or death by 58 percent compared to standard of care regimenFirst presentation of data from Phase 3 PERSEUS study...
Category: Clinical Trials
Posted: December 13, 2023
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
