X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

    Cytiva and NecstGen form strategic collaboration to accelerate development of cell and gene therapies

    Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

    Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

    Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

    Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

    Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Castor Launches CRO Partnership Program to Increase Adoption of Decentralized Clinical Trials

    Catalent acquires cell and gene therapy-focused MaSTherCell for $315m

    Cytiva and NecstGen form strategic collaboration to accelerate development of cell and gene therapies

    Astrazeneca Says Covid-19 Long-Acting Antibody Combination AZD7442 Rapidly Advances Into Phase III Clinical Trials

    Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    BioMed X Institute and Merck KGaA, Darmstadt, Germany, Extend Collaboration in Oncology

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma's VP3 Nasal Spray System

    New Combination Product for Symptoms of Seasonal Allergic Rhinitis Approved by US FDA with Aptar Pharma’s VP3 Nasal Spray System

    Cryoport and Cell Matters Enter into Strategic Partnership

    Cryoport and Cell Matters Enter into Strategic Partnership

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Evotec enters iPSC-based drug discovery partnership with Boehringer Ingelheim in ophthalmology

    Gilead Announces Results From Phase 3 Trial of Remdesivir in Patients With Moderate COVID-19

    Gilead Sciences Announces FDA Approval of Veklury for Treatment of Non-Hospitalized Patients at High Risk for COVID-19

    Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations

    Australia Therapeutic Goods Administration Grants Provisional Registration for Novavax COVID-19 Vaccine

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Americas

Tafinlar® receives FDA Breakthrough Therapy designation for non-small cell lung cancer with BRAF mutation

Yuvraj_pawp by Yuvraj_pawp
15th January 2014
in Americas, FDA Approvals, News

GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar® (dabrafenib) for treatment of patients with metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy. Dabrafenib is not approved or licensed anywhere in the world for use in this treatment setting.

The Breakthrough Therapy designation was based on interim efficacy and safety results from an ongoing Phase II study of dabrafenib administered orally to 25 patients who had NSCLC with the BRAF V600E mutation and who had received at least one previous course of chemotherapy. These interim results were presented at the 2013 American Society for Clinical Oncology Annual Meeting.

Lung cancer is the second most common cancer in both men and women and is by far the leading cause of cancer-related death worldwide. Recent advances in the understanding of tumour biology have identified genetic mutations, such as mutation in the BRAF protein, that can drive malignant cell growth and tumour proliferation in NSCLC. It is estimated that the BRAF V600E mutation targeted by dabrafenib is present in approximately 2.0% of patients with NSCLC.

About Breakthrough Therapy Designation

The Breakthrough Therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act and is intended to expedite development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. Breakthrough Therapy designation includes all the features of the Fast Track designation, as well as more intensive guidance from the FDA on a drug’s clinical development program.

Tags: America
Previous Post

Bayer HealthCare launches oncology treatment Xofigo in UK

Next Post

Galena Biopharma, Dr. Reddy's partner for NeuVax in India

Related Posts

NIH begins study of allergic reactions to Covid-19 vaccines
News

To Treat COVID WHO Approves Monoclonal Antibody Tocilizumab

18th February 2022
Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
News

Indian Scientists Claim To Design Vaccine For All Variants

9th February 2022
Drones for Delivery To Carry Pharmaceutical Weight Forward
News

Drones for Delivery To Carry Pharmaceutical Weight Forward

9th February 2022
America Facing Heart Health Issues Since The Pandemic Began
News

America Facing Heart Health Issues Since The Pandemic Began

8th February 2022
T2 Biosystems T2SARS-CoV-2 Panel Detects Omicron Subvariants
News

T2 Biosystems T2SARS-CoV-2 Panel Detects Omicron Subvariants

7th February 2022
OLUMIANT® (baricitinib) 2-mg Tablets gets FDA approval to treat adult patients with moderately to severely active Rheumatoid Arthritis
Manufacturing

Lilly announces $1 billion investment in new manufacturing facility in North Carolina

7th February 2022
Next Post

Galena Biopharma, Dr. Reddy's partner for NeuVax in India

Latest News

NIH begins study of allergic reactions to Covid-19 vaccines
News

To Treat COVID WHO Approves Monoclonal Antibody Tocilizumab

18th February 2022
Envirotainer introduces the RAP for the future - part of the Releye series
Packaging & Logistic

Envirotainer introduces the RAP for the future – part of the Releye series

14th February 2022
United Cargo Meets Growing Demand for Pharmaceuticals with New TempControl Containers
Packaging & Logistic

Opticooler receives technical approval by Japanese major airlines

14th February 2022
Aptar Pharma Launches HeroTracker Sense, Novel Connected Smart Device for Respiratory Disease
Press Statements

Aptar Pharma Launches HeroTracker Sense, Novel Connected Smart Device for Respiratory Disease

14th February 2022
Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
News

Indian Scientists Claim To Design Vaccine For All Variants

9th February 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

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

Log In