Daratumumab/hyaluronidase

Global Amyloidosis Market Spotlight Report 2021: GlaxoSmithKline, Bristol Myers Squibb, and Pfizer have the Highest Number of Completed Clinical Trials with 5 Each

Retrieved on: 
Friday, January 28, 2022

The publisher estimates that in 2017, there were approximately 90,500 incident cases of amyloidosis worldwide, with the highest proportion being the primary (amyloid light-chain; AL) amyloidosis type.

Key Points: 
  • The publisher estimates that in 2017, there were approximately 90,500 incident cases of amyloidosis worldwide, with the highest proportion being the primary (amyloid light-chain; AL) amyloidosis type.
  • Among multiple myeloma cases, the publisher estimates there were approximately 19,300 incident cases of AL amyloidosis worldwide in 2017.
  • GlaxoSmithKline, Bristol Myers Squibb, and Pfizer have the highest number of completed clinical trials for amyloidosis, with five trials each.
  • GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for amyloidosis.

Amyloidosis Market Spotlight Report 2021: Pipeline, Clinical Trials, Recent Events, Regulatory Events, 10-Year Disease Incidence Forecast, Drug-Specific Revenue Forecasts - ResearchAndMarkets.com

Retrieved on: 
Friday, January 28, 2022

This Market Spotlight report covers the Amyloidosis market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, and a 10-year disease incidence forecast, as well as presenting drug-specific revenue forecasts.

Key Points: 
  • This Market Spotlight report covers the Amyloidosis market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, and a 10-year disease incidence forecast, as well as presenting drug-specific revenue forecasts.
  • Among multiple myeloma cases, the publisher estimates there were approximately 19,300 incident cases of AL amyloidosis worldwide in 2017.
  • There are equal numbers of industry-sponsored drugs in active clinical development for amyloidosis in Phase I and Phase III.
  • GlaxoSmithKline leads industry sponsors with the highest overall number of clinical trials for amyloidosis.

Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse

Retrieved on: 
Monday, July 12, 2021

The approval marks Janssen's sixth indication for DARZALEX FASPRO in the treatment of multiple myeloma.

Key Points: 
  • The approval marks Janssen's sixth indication for DARZALEX FASPRO in the treatment of multiple myeloma.
  • "This introduces a new delivery option for multiple myeloma patients in the U.S. being treated with this regimen."
  • DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.
  • Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

DARZALEX®▼ (daratumumab) Subcutaneous (SC) Formulation Becomes the First Approved Treatment for Newly Diagnosed Systemic Light Chain Amyloidosis in Europe and Gains an Additional Approval in Pre-Treated Multiple Myeloma

Retrieved on: 
Tuesday, June 22, 2021

This approval makes this daratumumab-based regimen the first approved therapy for AL amyloidosis in Europe.

Key Points: 
  • This approval makes this daratumumab-based regimen the first approved therapy for AL amyloidosis in Europe.
  • The study includes 388 patients with newly diagnosed AL amyloidosis with measurable haematologic disease and one or more organs affected.
  • This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding daratumumab subcutaneous formulation for the treatment of patients with light chain amyloidosis.
  • Subcutaneous Daratumumab + Bortezomib, Cyclophosphamide, and Dexamethasone (VCd) in Patients With Newly Diagnosed Light Chain (AL) Amyloidosis: Updated Results From the Phase 3 ANDROMEDA Study.

Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX® (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible

Retrieved on: 
Saturday, June 12, 2021

"These results strongly support the use of daratumumab, lenalidomide and dexamethasoneas a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma."

Key Points: 
  • "These results strongly support the use of daratumumab, lenalidomide and dexamethasoneas a new standard of care to extend survival and improve clinical outcomes in transplant ineligible patients with newly diagnosed multiple myeloma."
  • Janssen is committed to exploring the potential of DARZALEX (daratumumab) for patients with multiple myeloma across the spectrum of the disease.
  • Overall Survival Results With Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma: Phase 3 MAIA Study.
  • Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study.

Updated Data Demonstrate Significant Improvement in Hematologic Complete Response with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis

Retrieved on: 
Wednesday, May 26, 2021

The study includes 388 patients with newly diagnosed AL amyloidosis with measurable hematologic disease and one or more organs affected.

Key Points: 
  • The study includes 388 patients with newly diagnosed AL amyloidosis with measurable hematologic disease and one or more organs affected.
  • DARZALEX FASPRO is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now AL amyloidosis.
  • DARZALEX FASPRO is indicated for the treatment of adult patients with multiple myeloma:
    DARZALEX FASPRO in combination with bortezomib, cyclophosphamide, and dexamethasone is indicated for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.
  • Light chain (AL) amyloidosis is a rare and potentially fatal hematologic disorder that can affect the function of multiple organs.

Genmab Announces that Janssen has Received Positive CHMP Opinion Recommending DARZALEX® (daratumumab) Subcutaneous (SC) Formulation for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Retrieved on: 
Friday, May 21, 2021

Janssen Pharmaceutica NV submitted Type II variation applications to the EMA for these indications in November 2020.

Key Points: 
  • Janssen Pharmaceutica NV submitted Type II variation applications to the EMA for these indications in November 2020.
  • Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone.
  • In the original design of the study, patients in the daratumumab plus Pd arm were treated with the intravenous (IV) formulation of daratumumab.
  • DARZALEX\xc2\xae SC (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved in the Europe for the treatment of multiple myeloma.

Janssen Receives Two Positive CHMP Opinions Recommending Expanded Use of DARZALEX®▼ (daratumumab) Subcutaneous (SC) Formulation for New Indications in Europe

Retrieved on: 
Friday, May 21, 2021

The study includes 388 patients with newly diagnosed AL amyloidosis with measurable haematologic disease and one or more organs affected.

Key Points: 
  • The study includes 388 patients with newly diagnosed AL amyloidosis with measurable haematologic disease and one or more organs affected.
  • The study, which was conducted in collaboration with the European Myeloma Network, enrolled 304 participants.10\nThe primary endpoint is progression-free survival (PFS) between treatment arms.
  • Secondary endpoints include rates of overall response rate (ORR), very good partial response (VGPR) or better, complete response (CR) or better and duration of response, among others.
  • European Commission Grants Marketing Authorisation for DARZALEX\xc2\xae\xe2\x96\xbc(Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications.

Caelum and Alexion Announce Upcoming CAEL-101 Data Presentations at the European Hematology Association Congress 2021

Retrieved on: 
Wednesday, May 12, 2021

Both presentations will include new data from the Phase 2 open-label dose escalation study evaluating the safety and tolerability of CAEL-101 in combination with standard-of-care (SoC) therapy in AL amyloidosis.

Key Points: 
  • Both presentations will include new data from the Phase 2 open-label dose escalation study evaluating the safety and tolerability of CAEL-101 in combination with standard-of-care (SoC) therapy in AL amyloidosis.
  • One will feature data studying safety and tolerability in AL amyloidosis patients treated with 1000 mg/m2 CAEL-101 in combination with cyclophosphamide-bortezomib-dexamethasone plus daratumumab.
  • View the full release here: https://www.businesswire.com/news/home/20210512006005/en/\nThe abstracts accepted for e-poster presentations are listed below and are now available on the EHA website.
  • In 2019, Caelum entered a collaboration agreement with Alexion under which Alexion acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company.

Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis

Retrieved on: 
Friday, January 15, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • "We are delighted that DARZALEX FASPRO utilizing our ENHANZE technology has become the first and only FDA-approved treatment for newly diagnosed patients with AL amyloidosis," said Dr. Helen Torley, president and chief executive officer.
  • The study evaluated DARZALEX FASPRO in combination with VCd, compared with VCd alone, a common treatment regimen offered to adult patients with newly diagnosed AL amyloidosis.
  • Subcutaneous Daratumumab + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Primary Results from the Phase 3 ANDROMEDA Study.