• 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

European Commission approves Venclyxto-based combinations for acute myeloid leukaemia

European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy

PRN by PRN
June 6, 2021
in Global Pharma News
17 1
0
European Commission approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy

Roche Logo

11
SHARES
27
VIEWS
  • With hypomethylating agents significantly improved complete response rates in certain adults with newly diagnosed acute myeloid leukaemia
  • In the VIALE-A study, Venclyxto plus azacitidine significantly improved overall survival in patients ineligible for intensive chemotherapy, a patient population who typically have a five-year overall survival rate of less than 10%1
  • Study data reinforces the potential of Venclyxto-based combinations to provide clinically meaningful benefits in difficult to treat blood cancers

Roche announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidine and decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

“This Venclyxto approval is a critical step in providing new therapeutic options for patients in the EU newly diagnosed with AML who cannot tolerate the side effects of, or are ineligible for, intensive chemotherapy,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Venclyxto based combinations continue to show meaningful clinical benefits in AML patients, who would otherwise have a poor prognosis.”

The approval is based on the results of two key studies, phase III VIALE-A and phase I/II M14-358, of Venclyxto in combination with hypomethylating agents in adults with newly diagnosed AML, who are ineligible for intensive chemotherapy. Results from the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34%, compared to azacitidine alone (HR=0.66; 95% CI: 0.52, 0.85; p<0.001). The median overall survival was 14.7 months (95% CI: 11.9, 18.7) in the Venclyxto group and 9.6 months (95% CI: 7.4, 12.7) in the control group. The Venclyxto combination more than doubled the complete responses (CRs), with a CR rate of 37% (95% CI: 31, 43) compared to 18% (95% CI: 12, 25) in the comparator arm (p<0.001).

The Venclyxto plus azacitidine combination also led to higher rates of composite complete remission (CR + CR with incomplete blood count recovery [CR + CRi]) at 66% (95% CI: 61, 72) compared to 28% (95% CI: 21, 36) with azacitidine alone (p<0.001). The most frequently reported serious adverse reactions (≥5%) in patients receiving Venclyxto in combination with azacitidine were febrile neutropenia, pneumonia, sepsis and haemorrhage.

Results from the M14-358 study demonstrated that patients receiving Venclyxto in combination with decitabine achieved a CR + CRi rate of 74% (95% CI: 55, 88). The most frequently reported serious adverse reactions (≥5%) were febrile neutropenia, pneumonia, bacteraemia and sepsis.

Today’s approval reinforces the potential of Venclyxto-based combinations to provide clinically meaningful benefits across several disease areas, including AML. Venclexta® (venetoclax) is already approved in the US in combination with azacitidine, decitabine, or low dose cytarabine for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta/Venclyxto is also approved in the US and EU in combination with MabThera®/Rituxan® (rituximab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy; in combination with Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of adult patients with previously untreated CLL; and as a monotherapy for the treatment of CLL in the presence of 17p deletion or TP53 mutation in people who are unsuitable for or have failed a B-cell receptor pathway inhibitor.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US.

Tags: roche
Previous Post

Pfizer Receive FDA Approval for MYFEMBREE®, Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids

Next Post

Lupin Announces Achievement of Key Milestones for its Clinical Stage MEK Inhibitor Compound

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
Lupin Announces Achievement of Key Milestones for its Clinical Stage MEK Inhibitor Compound

Lupin Announces Achievement of Key Milestones for its Clinical Stage MEK Inhibitor Compound

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?