• Contact us
  • Advertise with us
  • Login
Tashi Pharma
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
No Result
View All Result
Home Global Pharma News

Investigational Combination of Aliqopa® (copanlisib) and rituximab helps in non-Hodgkin’s Lymphoma

PRN by PRN
April 12, 2021
in Global Pharma News
7 0
0
Bayer receives approval for Vitrakvi™ in Japan
5
SHARES
11
VIEWS
  • In the Phase III trial CHRONOS-3 of 458 patients with indolent non-Hodgkin’s Lymphoma (iNHL), the investigational combination of Aliqopa and rituximab was statistically significant in delaying disease progression or death (HR=0.52, 95% CI 0.39, 0.69) compared to rituximab and placebo, with a median progression-free survival (PFS) of 21.5 months (95% CI 17.8, 33.0) versus 13.8 months (95% CI 10.2, 17.5)
  • The CHRONOS-3 trial included several prespecified iNHL subgroups including follicular lymphoma (FL; n=275), marginal zone lymphoma (MZL; n=95), small lymphocytic lymphoma (SLL; n=50), and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM; n=38)
  • Bayer is discussing the data from CHRONOS-3 with health authorities worldwide

Results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant improvement in progression-free survival (PFS) with the investigational combination of Aliqopa® (copanlisib) and rituximab given intravenously in patients with relapsed indolent non-Hodgkin’s Lymphoma (iNHL) compared to the combination of rituximab and placebo. After a median follow-up of 19.2 months, patients treated with this combination had a median PFS of 21.5 months (95% CI 17.9, 33.0) versus 13.8 months in patients treated with rituximab and placebo (95% CI 10.2, 17.5), (HR=0.52, p=0.000002). No new safety signals were identified for Aliqopa in the combination arm of the study. The data will be presented in a Clinical Trials Plenary Session on April 10 at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 and simultaneously published in The Lancet Oncology.

CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled trial with the objective to evaluate whether Aliqopa in combination with rituximab is superior to placebo plus rituximab in extending PFS in patients with relapsed iNHL following at least one prior rituximab-containing therapy. Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included.

In 2017, Aliqopa was approved for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies based on the results of a single-arm, multicenter, Phase II clinical trial (CHRONOS-1). Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

 

 

Tags: bayerPharma NewsPharmareg News
Previous Post

Solara & Aurore merge to become one of India’s largest pure play API/CRAMS company

Next Post

mAbxience Expanding Biosimilar and CDMO Manufacturing Capacity with ABEC 4,000 Liter Single-Use Bioreactor

PRN

PRN

Related Posts

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine
Global Pharma News

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

by admin
February 23, 2022
NDAs of Sandoz Inc have been acquired by ANI Pharmaceuticals
Global Pharma News

Sandoz launches generic lenalidomide in 19 countries across Europe

by admin
February 20, 2022
Revenue of Pfizer up by 95% for year 2021
Global Pharma News

Revenue of Pfizer up by 95% for year 2021

by admin
February 16, 2022
FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Global Pharma News

FDA Authorizes New Monoclonal Antibody that Retains Activity Against Omicron Variant

by admin
February 12, 2022
WHO prequalifies first monoclonal antibody - tocilizumab – to treat COVID-19
Global Pharma News

WHO prequalifies first monoclonal antibody – tocilizumab – to treat COVID-19

by admin
February 12, 2022
Next Post
mAbxience Expanding Biosimilar and CDMO Manufacturing Capacity with ABEC 4,000 Liter Single-Use Bioreactor

mAbxience Expanding Biosimilar and CDMO Manufacturing Capacity with ABEC 4,000 Liter Single-Use Bioreactor

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Recent News

Zydus to launch Oxemia

Zydus to launch Oxemia (Desidustat) a treatment for Anemia in patients with Chronic Kidney Disease (CKD)

March 7, 2022
FDA Urges Companies to be 'Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

US FDA Urges Companies to be ’Recall Ready’ to Protect Public Health

March 6, 2022
FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

March 5, 2022
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

US FDA publishes guidance on Initiation of Voluntary Recalls

March 5, 2022
Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

March 5, 2022

Browse by Category

  • Articles
  • Company Focus
  • EDQM
  • EMA
  • European Commision
  • Global Pharma News
  • Guideline News
  • Health Canada
  • Indian Pharma News
  • Interview
  • Medsafe
  • MHRA
  • SAHPRA
  • US FDA
  • Webinar

Browse by Tags

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Contact us

Address:Pharma Reg News, First floor, Shop no.1 , Plot no 241,242, Near Fire station, GIDC, Ankleshwar, Gujarat - 393002.
Phone:+91 8511586232, +91 9029066605
Email:author@pharmaregnews.com

Browse by Tag

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Advertise with us

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • bioanalytical
    • Clinical
  • Webinar
  • Contact us
  • Advertise with us
  • Login

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
Are you sure want to unlock this post?
Unlock left : 0
Are you sure want to cancel subscription?