Plasmacytoid dendritic cell

Horizon Therapeutics plc Announces First Patient Enrolled in Phase 2 Trial Evaluating HZN-7734 for the Treatment of Systemic Lupus Erythematosus

Retrieved on: 
Tuesday, June 29, 2021

HZN-7734 also improved Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity ( CLASI-A ) scores, a clinical measure of cutaneous lupus, versus placebo.

Key Points: 
  • HZN-7734 also improved Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity ( CLASI-A ) scores, a clinical measure of cutaneous lupus, versus placebo.
  • The composite primary endpoint of the Phase 2 trial is change in the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (BICLA) and reduction in oral glucocorticoid dose after 48 weeks.
  • Additional trial endpoints include other measures of both lupus disease activity and oral glucocorticoid reduction.
  • Depleting plasmacytoid dendritic cells reduces local type I interferon responses and disease activity in subjects with cutaneous lupus.

Menarini Group and Nippon Shinyaku Enter into an Exclusive License Agreement to Develop and Commercialize ELZONRIS® (Tagraxofusp) in Japan

Retrieved on: 
Monday, March 29, 2021

ELZONRIS (tagraxofusp) is the first approved treatment for patients with BPDCN, and the first approved CD123-targeted therapy, in both the United States and Europe.

Key Points: 
  • ELZONRIS (tagraxofusp) is the first approved treatment for patients with BPDCN, and the first approved CD123-targeted therapy, in both the United States and Europe.
  • "Patients with BPDCN have limited treatment options and we are excited to be collaborating closely with Nippon Shinyaku to make ELZONRIS (tagraxofusp) available to patients in Japan."
  • ELZONRIS(tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • ELZONRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.

Menarini Group and Nippon Shinyaku Enter into an Exclusive License Agreement to Develop and Commercialize ELZONRIS® (Tagraxofusp) in Japan

Retrieved on: 
Monday, March 29, 2021

Elzonris was originally developed by Stemline Therapeutics, now part of the Menarini Group.

Key Points: 
  • Elzonris was originally developed by Stemline Therapeutics, now part of the Menarini Group.
  • "Patients with BPDCN have limited treatment options and we are excited to be collaborating closely with Nippon Shinyaku to make ELZONRIS (tagraxofusp) available to patients in Japan."
  • "Through this development and commercial partnership, we look forward to advancing ELZONRIS as a potential new treatment option for patients suffering from BPDCN."
  • ELZONRIS(tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Menarini Receives European Commission Approval of ELZONRIS (tagraxofusp), for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Retrieved on: 
Thursday, January 21, 2021

ELZONRIS(tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Key Points: 
  • ELZONRIS(tagraxofusp) is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • ELZONRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.
  • The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor.
  • The World Health Organization (WHO) termed this disease "BPDCN" in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm.

ImmunoGen Presents Updated Findings from Phase 1/2 Study of IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm at ASH Annual Meeting

Retrieved on: 
Saturday, December 5, 2020

Despite currently available therapies, outcomes for relapsed/refractory patients remain poor and there is an urgent need to develop better-tolerated treatment options in the frontline setting.

Key Points: 
  • Despite currently available therapies, outcomes for relapsed/refractory patients remain poor and there is an urgent need to develop better-tolerated treatment options in the frontline setting.
  • These updated safety and efficacy findings for IMGN632 in patients with relapsed/refractory BPDCN are encouraging, and I look forward to advancing IMGN632 into pivotal development.
  • IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL).
  • For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995.

CHMP Adopted Positive Opinion for ELZONRIS (tagraxofusp), for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Retrieved on: 
Friday, November 13, 2020

The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU).

Key Points: 
  • The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU).
  • For this reason, we are particularly thrilled to be one step closer to making ELZONRIS available for BPDCN patients".
  • The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor.
  • The World Health Organization (WHO) termed this disease "BPDCN" in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm.

CHMP Adopted Positive Opinion for ELZONRIS (tagraxofusp), for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Retrieved on: 
Friday, November 13, 2020

The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU).

Key Points: 
  • The CHMP opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorization for human medicines throughout the European Union (EU).
  • For this reason, we are particularly thrilled to be one step closer to making ELZONRIS available for BPDCN patients".
  • The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor.
  • The World Health Organization (WHO) termed this disease "BPDCN" in 2008; previous names included blastic NK cell lymphoma and agranular CD4+/CD56+ hematodermic neoplasm.

ImmunoGen Announces FDA Breakthrough Therapy Designation for IMGN632 in Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm

Retrieved on: 
Monday, October 5, 2020

ImmunoGen, Inc. , (Nasdaq: IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Key Points: 
  • ImmunoGen, Inc. , (Nasdaq: IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • According to FDA guidelines, Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and have generated preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapy.
  • Updated data from the IMGN632 monotherapy BPDCN dose expansion cohort will be presented at ASH this December.
  • IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL).

Global Blastic Plasmacytoid Dendritic Cell Neoplasm Industry to 2030 - Insights, Epidemiology, and Market Forecast - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 23, 2020

The "Blastic plasmacytoid dendritic cell neoplasm (BPDCN) - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Blastic plasmacytoid dendritic cell neoplasm (BPDCN) - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The Blastic plasmacytoid dendritic cell neoplasm (BPDCN) market report provides current treatment practices, emerging drugs and their market share of the individual therapies, current and forecasted BPDCN symptoms market size from 2017 to 2030 segmented by seven major markets.
  • Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare entity grouped with the acute myeloid leukemia-related precursor neoplasms in the 2008 World Health Organization classification.
  • Launch of emerging therapies will significantly impact the Blastic plasmacytoid dendritic cell neoplasm (BPDCN) market
    Organize sales and marketing efforts by identifying the best opportunities for Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) - Epidemiology Forecast - 2030 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 21, 2020

The "Blastic plasmacytoid dendritic cell neoplasm (BPDCN) - Epidemiology Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Blastic plasmacytoid dendritic cell neoplasm (BPDCN) - Epidemiology Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The Blastic plasmacytoid dendritic cell neoplasm (BPDCN) report covers a detailed overview explaining its causes, symptoms, classification, pathophysiology, diagnosis and treatment patterns
    The Blastic plasmacytoid dendritic cell neoplasm (BPDCN) Epidemiology Report and Model provide an overview of the risk factors and global trends of Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan)
    The report provides insight about the historical and forecasted patient pool of Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK) and Japan
    The report provides the segmentation of the Blastic plasmacytoid dendritic cell neoplasm (BPDCN) epidemiology by Incident Cases of Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in 7MM.
  • The report provides the segmentation of the Blastic plasmacytoid dendritic cell neoplasm (BPDCN) epidemiology by gender-specific Incident Cases of Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in 7MM.
  • The report provides the segmentation of the Blastic plasmacytoid dendritic cell neoplasm (BPDCN) epidemiology by age-specific Prevalent Cases of Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in 7MM.