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Related Clinical Trials

Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)

NCT04146051RecruitingPhase 2
Cartesian Therapeutics
Posted 12/4/2019

Related Topics

J&J Seeks Approval for Subcutaneous Darzalex in Smoldering Multiple Myeloma

Johnson & Johnson has submitted applications to the EMA and FDA for subcutaneous Darzalex (daratumumab) as a monotherapy for high-risk smoldering multiple myeloma (SMM).
The applications are based on positive phase 3 AQUILA trial results, which showed significant improvement in progression-free survival (PFS) with SC Darzalex compared to active monitoring.

Johnson & Johnson Seeks FDA Approval for Daratumumab in High-Risk Smoldering Multiple Myeloma

Johnson & Johnson has submitted an application to the FDA for daratumumab as a subcutaneous monotherapy for high-risk smoldering multiple myeloma (SMM).
The application is supported by data from the phase 3 AQUILA study, which evaluated daratumumab's efficacy in prolonging progression-free survival in SMM patients.

Darzalex Shows Promise in Smoldering Myeloma, Awaiting Regulatory Decision

Johnson & Johnson's Darzalex Faspro significantly improved progression-free survival in high-risk smoldering multiple myeloma patients compared to active monitoring.
The AQUILA phase 3 trial demonstrated a 51% reduction in disease progression or death with Darzalex, potentially setting a new treatment paradigm.

Daratumumab Seeks Approval for High-Risk Smoldering Multiple Myeloma

Applications have been submitted to the FDA and EMA for subcutaneous daratumumab monotherapy in high-risk smoldering multiple myeloma.
The submissions are based on data from the phase 3 AQUILA trial, with initial findings to be presented at the 2024 ASH Annual Meeting.

Johnson & Johnson Seeks Approval for Darzalex Faspro in Smoldering Multiple Myeloma

Johnson & Johnson has submitted applications to the FDA and EMA for Darzalex Faspro to treat high-risk smoldering multiple myeloma.
The applications are based on the Phase 3 AQUILA study, which evaluated Darzalex Faspro versus active monitoring in patients with the condition.

European Commission Approves J&J's Darzalex Regimen for Newly Diagnosed Multiple Myeloma

The European Commission has approved Johnson & Johnson's Darzalex subcutaneous formulation for newly diagnosed multiple myeloma (NDMM).
Darzalex, combined with bortezomib, lenalidomide, and dexamethasone (VRd), is authorized for NDMM patients eligible for autologous stem cell transplant (ASCT).

European Commission Approves Darzalex SC with VRd for Newly Diagnosed Multiple Myeloma

The European Commission has approved Darzalex subcutaneous formulation (SC) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) patients eligible for autologous stem cell transplant (ASCT).
The approval is based on the Phase 3 PERSEUS study, which demonstrated a 58% reduction in the risk of disease progression or death compared to VRd alone.

CHMP Recommends Daratumumab-Based Quadruplet Regimen for Newly Diagnosed Multiple Myeloma

The CHMP has recommended daratumumab subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for transplant-eligible multiple myeloma patients.
The recommendation is based on the Phase 3 PERSEUS study, which demonstrated a 60% reduction in disease progression or death risk with the D-VRd regimen.

FDA Approves Darzalex Faspro Quadruplet Regimen for Transplant-Eligible Multiple Myeloma

The FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant.
The approval was based on the Phase 3 PERSEUS study, which demonstrated a 60% reduction in the risk of disease progression or death with the D-VRd regimen compared to VRd alone.

Significant Improvement in Progression-Free Survival with SARCLISA Combination Therapy for Previously Treated Multiple Myeloma

A Phase 3 trial reveals that patients with previously treated multiple myeloma who stopped responding to Revlimid experienced a median progression-free survival of 41.7 months with SARCLISA combined with Kyprolis and dexamethasone, compared to 20.8 months with Kyprolis and dexamethasone alone.

Reference News

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Daratumumab Reduces Risk of Progression in High-Risk Smoldering Multiple Myeloma Patients
insideprecisionmedicine.com · Dec 12, 2024

Daratumumab significantly reduces risk of smoldering multiple myeloma progressing to active disease, per Mayo Clinic's A...

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From Blinatumomab to Venetoclax: Highlights From the 66th American Society ... - Pharmacy Times
pharmacytimes.com · Jan 19, 2025

At ASH 2024, key trials highlighted advancements in hematology and oncology: Blinatumomab with chemotherapy improved DFS...

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Sanofi builds case for Sarclisa, challenging J&J's Darzalex
pharmaphorum.com · May 11, 2020

Sanofi's Sarclisa shows promise in phase 3 IKEMA trial for earlier multiple myeloma treatment, aiming to compete with J&...

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Daratumumab Demonstrates Significant Benefit in High-Risk Smoldering Myeloma - Pharmacy Times
pharmacytimes.com · Dec 8, 2024

The AQUILA study (NCT03301220) demonstrated that early intervention with daratumumab (DARA) significantly reduced the ri...

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Experts Debate AQUILA Trial Findings in Smoldering Multiple Myeloma | MedPage Today
medpagetoday.com · Dec 16, 2024

The AQUILA trial showed single-agent daratumumab delayed progression in high-risk smoldering multiple myeloma. Experts d...

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pharmiweb.com · Dec 10, 2024

Sarclisa-based combinations show significant clinical benefits in NDMM patients, with higher MRD negativity rates and im...

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FDA sets date for Sarclisa in first-line multiple myeloma
pharmaphorum.com · May 27, 2024

Sanofi awaits FDA decision in September for Sarclisa as first-line multiple myeloma therapy. Approved for relapsed cases...

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Daratumumab Reduces Risk of Progression in High-Risk Smoldering Multiple Myeloma Patients
insideprecisionmedicine.com · Dec 13, 2024

Daratumumab significantly reduces risk of smoldering multiple myeloma progressing to active disease, per Mayo Clinic's A...

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DARZALEX® (daratumumab) subcutaneous formulation shows 51 - GlobeNewswire
globenewswire.com · Dec 8, 2024

DARZALEX® (daratumumab) SC significantly delayed progression from high-risk smouldering multiple myeloma (SMM) to active...

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Sanofi gets first OK for isatuximab for myeloma, challenging J&J's Darzalex
pharmaphorum.com · Apr 29, 2025

Sanofi's isatuximab, branded as Sarclisa, gains FDA approval as a third-line multiple myeloma treatment, rivaling J&J's ...

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Recent hematology and oncology advancements include cilta-cel plus daratumumab for multiple myeloma, acalabrutinib and v...

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J&J drug helps delay multiple myeloma in high-risk patients - Pharmacy.biz
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Darzalex, a monoclonal antibody targeting CD38, significantly reduced the risk of progression to multiple myeloma and im...

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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) significantly delays progression from high-risk smoldering multipl...

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Blackstone funds new trials of Sanofi's Sarclisa in myeloma
pharmaphorum.com · Mar 14, 2022

Sanofi partners with Blackstone for €300M funding to accelerate Sarclisa's subcutaneous formulation trials for multiple ...

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J&J's DARZALEX FASPRO Shows Breakthrough 51% Risk Reduction in Multiple Myeloma Trial
stocktitan.net · Dec 8, 2024

DARZALEX FASPRO® significantly delayed progression from high-risk SMM to active MM and extended overall survival in the ...

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ASH: Sanofi’s Sarclisa carves out a multiple myeloma niche
pharmaphorum.com · Dec 12, 2023

Sanofi's Sarclisa showed improved MRD negativity rates in multiple myeloma patients when added to KRd regimen, as per Is...

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Daratumumab Continues to Show Activity in Smoldering Multiple Myeloma - Cancer Network
cancernetwork.com · Mar 23, 2025
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br.advfn.com · Dec 12, 2024

Sarclisa combinations showed significant benefits in newly diagnosed multiple myeloma (NDMM) patients, with higher MRD n...

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Sanofi's multiple myeloma drug approved in EU
pharmaphorum.com · May 2, 2025
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PFS, OS Significantly Improved by Daratumumab for Smoldering Multiple Myeloma
cancernetwork.com · Dec 8, 2024

Subcutaneous daratumumab significantly improved PFS and OS vs active monitoring in high-risk smoldering multiple myeloma...

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prnewswire.com · Dec 8, 2024

DARZALEX FASPRO significantly delayed progression from high-risk SMM to active MM and extended overall survival in Phase...

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Daratumumab treatment shows promise for high-risk smoldering multiple myeloma in phase 3 trial
news-medical.net · Dec 11, 2024

Daratumumab significantly reduces risk of progression to active multiple myeloma and improves survival in high-risk smol...

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Press Release: ASH: Sarclisa combinations demonstrated significant benefits in newly ...
sanofi.com · Dec 9, 2024

Sarclisa-based combinations showed significant benefits in newly diagnosed multiple myeloma patients, with higher MRD ne...

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December 2024 saw significant updates in cell and gene therapies: Cilta-cel showed higher MRD negativity in multiple mye...

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Subcutaneous daratumumab (Darzalex Faspro) significantly reduced disease progression or death risk and improved overall ...

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ASH24: Darzalex in smoldering myeloma, Merck's ADC data and Novo's sickle cell drug
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Darzalex reduced smoldering multiple myeloma progression risk by 51%; BEAM-101 increased fetal hemoglobin in sickle cell...

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ASH 2024: Pharmacists Play Key Role in Incorporating Venetoclax, Blinatumomab for ...
pharmacytimes.com · Dec 7, 2024

Amir Ali, PharmD, discusses abstracts on shorter venetoclax durations in AML and blinatumomab in B-ALL, highlighting the...

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An Assortment of Journal Abstracts to Enhance Oncology Care
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Kiadis Pharma and Sanofi to unlock power of natural killer cells in multiple myeloma
pharmaphorum.com · May 5, 2025
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ASH 2024 Recap: Movement in Multiple Myeloma, Cell Therapy, Sickle Cell Disease & More
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ASH 2024 highlights include GSK's Blenrep Phase 3 data supporting re-market, J&J's Darzalex Faspro delaying progression ...

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Sanofi's Sarclisa gets one up on rival Darzalex in myeloma
pharmaphorum.com · Apr 22, 2025

FDA approves Sanofi's Sarclisa as a first-line therapy for multiple myeloma, offering a competitive edge against Johnson...

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