DARZALEX FASPRO ® non|inferiority trial vs DARZALEX ® IV

Analysis Finds Daratumumab Combo Offers Better PFS Than ...

The trial (NCT05511428) will study home-based subcutaneous daratumumab and hyaluronidase-fihj, sold as Darzalex Faspro, for patients with MM.

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

This approval is supported by data from the Phase 3 PERSEUS study evaluating DARZALEX FASPRO® in a regimen that included D-VRd induction and ...

Genmab Announces U.S. FDA Approval of Subcutaneous

DARZALEX FASPRO is a fixed-dose formulation that can be administered over approximately three to five minutes, significantly less time than ...

DARZALEX® (daratumumab)-based regimens significantly improve ...

88 percent of transplant-eligible patients achieved a complete response or better, and 47 percent of patients sustained MRD-negativity for ...

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

FDA has approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adult patients with newly diagnosed or relapsed/refractory ...

Daratumumab and hyaluronidase-fihj (subcutaneous route)

Darzalex Faspro. Back to top. Description. Daratumumab and ... For non-prescription products, read the label or package ingredients carefully.

FDA Approves Darzalex Faspro plus Pomalyst and Dexamethasone ...

On July 9, 2021, the FDA accelerated the approval of a new indication for daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech), ...

1404 Effect of Intravenous Immunoglobulin on Infections in Multiple ...

In this retrospective case-crossover study of patients receiving daratumumab, we compared the rates of infection while on and off intravenous immunoglobulin ( ...

Multiple Myeloma Final analysis of the phase III non-inferiority ...

In summary, DARA SC and DARA IV continue to demonstrate similar efficacy and safety, with a low rate of infusion-related reactions (12.7% vs.

Daratumumab (Darzalex), Daratumumab/Hyaluronidase-fihj ...

Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. ... Darzalex or Darzalex Faspro is prescribed for relapsed or refractory ...

FDA Approves Daratumumab and Hyaluronidase-fihj with Bortezomib

Treatment with Darzalex Faspro-VRd resulted in a reduction in the risk of disease progression or death by 60% compared to VRd alone (hazard ...

DARZALEX FASPRO® - Janssen CarePath

This permanent code replaces all HCPCS codes previously used to describe DARZALEX FASPRO®, including any miscellaneous or temporary codes. For claims with dates ...

What is Darzalex Faspro? - Patient Power

Myeloma experts discuss the difference between Darzalex Faspro and the daratumumab (Darzalex) injection, how it's used to treat multiple ...

Daratumumab and Hyaluronidase-fihj–Based Quadruplet Regimen ...

Subcutaneous Darzalex Faspro was first approved by the FDA in May 2020 for indications in MM that included new diagnosis, transplant ...

U.S. Food and Drug Administration Approves DARZALEX FASPRO ...

37 percent, respectively). In addition, there were fewer systemic ARRs with DARZALEX FASPRO™ versus intravenous DARZALEX® (13 percent vs. 34 ...

Official Consumer Website | DARZALEX® & DARZALEX FASPRO ...

Learn about adult treatment with DARZALEX® and DARZALEX FASPRO®. See Full Prescribing & Safety Information.

Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) Monotherapy

... non-inferiority trial randomizing 263 patients to daratumumab and hyaluronidase-fihj and 259 to intravenous daratumumab (daratumumab IV).

talk with your doctor about DARZALEX FASPRO

A study confirmed that DARZALEX FASPRO® gave patients results comparable to the IV formulation of DARZALEX® (daratumumab) in treating multiple myeloma when used ...

Jurisdiction M Part A - Medical Review - Palmetto GBA

Darzalex and Darzalex-Faspro (Daratummumab) Checklist. The purpose of the ... The reviews with edit effectiveness are presented in this article. 6/4/2024Targeted ...

FDA Approves PTC Therapeutics' Kebillidi for Aromatic L-Amino ...

Johnson & Johnson Submits Regulatory Applications for Darzalex Faspro for High-Risk Smoldering Multiple Myeloma ... and genetic testing is roughly ...