DARZALEX FASPRO ® non|inferiority trial vs DARZALEX ® IV

DARZALEX FASPRO ® non-inferiority trial vs DARZALEX ® IV

Phase 3, randomized, open-label, non-inferiority, multicenter trial comparing DARZALEX FASPRO monotherapy vs DARZALEX monotherapy in 522 adult patients.

DARZALEX + DARZALEX FASPRO - Intravenous vs Subcutaneous ...

With the longer follow-up, the overall response rate (ORR) was 43.7% in the DARZALEX FASPRO arm and 39.8% in the DARZALEX arm. Median PFS was 5.6 months vs 6.1 ...

Final analysis of the phase III non-inferiority COLUMBA study of ...

... study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma ... DARZALEX FASPRO™ (daratumumab and ...

Clinical Results - Darzalex

41% (about 4 of 10) of patients responded to treatment with DARZALEX FASPRO ® compared to 37% (about 4 of 10) who responded to treatment with DARZALEX®. In the ...

a multicentre, open-label, non-inferiority, randomised, phase 3 trial

Background: Intravenous daratumumab for treatment of patients with multiple myeloma involves a lengthy infusion that affects quality of life, and infusion- ...

a multicentre, open-label, non-inferiority, randomised, phase 3 trial

Intravenous daratumumab for treatment of patients with multiple myeloma involves a lengthy infusion that affects quality of life, and ...

DARZALEX FASPRO®-based quadruplet regimen significantly ...

The CR or better rate was 81.2 percent with D-VRd vs 61.6 percent with VRd (P<0.0001). Overall survival data are not yet mature. The overall ...

FDA approves daratumumab and hyaluronidase-fihj for multiple ...

On May 1, 2020, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO, Janssen Biotech, Inc.) for adult patients ...

Dosing and Administration Guide - Darzalex

INDICATIONS. DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:.

Subject: Daratumumab (Darzalex®) Infusion and Daratumumab ...

Since the initial approval, Darzalex Faspro has gained the three additional indications and now includes the eight MM indications IV Darzalex ...

Understanding DARZALEX and DARZALEX FASPRO - Issuu

Darzalex is the first monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) that targets the CD38 protein on the surface ...

DARZALEX® (daratumumab)-based maintenance regimens show ...

Minimal residual disease (MRD)-negativity rate of 10-5 more than doubled by 12 months with DARZALEX FASPRO® in maintenance therapy compared ...

Daratumumab Plus Standard Therapy for Multiple Myeloma - NCI

A large randomized clinical trial for people newly diagnosed with multiple myeloma has found that adding the drug daratumumab (Darzalex) to a standard ...

DARZALEX FASPRO - Adverse Event - Administration-Related ...

DARZALEX FASPRO can cause severe and/or serious IRRs, including anaphylactic reactions. In clinical trials, approximately 9% (77/898) of patients experienced ...

Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for ...

An evaluation of subcutaneous daratumumab combined with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of transplantation-eligible patients

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj ...

The co-primary endpoint of remaining therapeutic drug concentration (maximum C trough) of DARZALEX FASPRO ® was also non-inferior to intravenous ...

Darzalex (Daratumumab) | International Myeloma Foundation

Darzalex enlists immune system cells to help attack and kill myeloma cells. It is administered intravenously (infused from the vein, or IV) at a doctor's office ...

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj ...

DARZALEX FASPRO or Intravenous Daratumumab in COLUMBA. Adverse Reaction ... non-inferiority study. Eligible patients were required to have relapsed or ...

FDA Approves Darzalex Faspro as Injection Therapy for Multiple ...

The time patients lived without disease worsening and safety were also similar for the two formulations, but fewer patients on Darzalex Faspro ...

This label may not be the latest approved by FDA. For current ...

as monotherapy. Table 1: DARZALEX FASPRO dosing schedule in combination with lenalidomide or pomalidomide and dexamethasone. (4-week cycle) and ...