X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

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

AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for Investigational ABT

Yuvraj_pawp by Yuvraj_pawp
11th July 2016
in Research & Development

AbbVie a global biopharmaceutical company, announced that the U.S. FDA granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG), known to be highly aggressive and difficult to treat brain tumors found at the base of the brain.1

 

Though brainstem tumors are extremely rare among adults, they comprise approximately 10-15 percent of all pediatric brain tumors. DIPG is the most common subtype of tumor in this anatomical region and the second most common malignant brain tumor of childhood, with an estimated 200-400 children affected each year in the United States.2,3,8

 

The FDA granted the Rare Pediatric Disease Designation based on a proposed pediatric sub-study “nested” within the ongoing Phase 2 study of ABT-414 in adults with recurrent EGFR-amplified glioblastoma, conducted in collaboration with the European Organization for Research and Treatment of Cancer (EORTC).4,5

 

“Pediatric patients with high grade gliomas have a rare and fatal disease.2 This Rare Pediatric Designation, a first for AbbVie, is an important advancement as we continue to evaluate ABT-414 and its potential to help this group of patients who desperately need a new treatment option,” said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. “The proposal of including a nested cohort within an adult global trial is an endeavor that we hope may bring more treatments to pediatric patients.”

 

About ABT-414
ABT-414 is an investigational monoclonal antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR) developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.6 AbbVie is evaluating it for the treatment of adult patients with EGFR-amplified glioblastoma, an aggressive malignant primary brain tumor.6,7 In 2014, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency granted Orphan Drug Designation for the treatment of adult glioblastoma and glioma, respectively.4,5 In 2016, the FDA granted Rare Disease Designation to ABT-414 for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Gliomas (DIPG). ABT-414 is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

 

About Pediatric High Grade Gliomas
Diffuse Intrinsic Pontine Glioma (DIPG) is a type of high grade glioma (HGG).8 HGG represents one of the most common central nervous system (CNS) tumors among adults; however, they comprise only approximately 8-12 percent of all CNS tumors in pediatric patients.2 Pediatric HGG are highly aggressive tumors that account for a significant amount of morbidity and mortality among children.2Despite numerous treatment approaches, five-year survival outcomes range from 15-35 percent and the majority of children succumb to their disease.2,9

About Glioblastoma
Glioblastoma is the most common and most aggressive type of malignant primary brain tumor.7 Prior to diagnosis, patients may experience headache, vision problems, nausea/vomiting, personality changes and seizures.7 For adults with more aggressive glioblastoma, treated with concurrent Temozolamide and radiation therapy, median survival is about 14.6 months.9 Treatment for glioblastoma remains challenging.7 Standard treatment is surgical resection, radiotherapy and concomitant adjunctive chemotherapy.9

About AbbVie in Oncology
AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and most importantly patients, to discover, develop and provide new therapies that will have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers. We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015 and Stemcentrx in 2016, and through several collaborations, AbbVie’s oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly two hundred clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit https://abbvieoncology.com.


About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

1 Warren, K.E., Diffuse intrinsic pontine glioma: poised for progress. Front Oncol. 2012; 2: 205.
2 Fangusaro, J. Pediatric high grade glioma: a review and update on tumor clinical characteristics and biology. Front Oncol. 2012; 2: 105.
3 Central Brain Tumor Registry of the United States (2010) CBTRUS Statistical Report: Primary Brain and Central Nervous System Tumors Diagnosed in the United States in 2004-2006 (Central Brain Tumor Registry of the United States, Hinsdale, IL).
4 U.S. Food and Drug Administration (2014). Orphan Drug Designations and Approvals.https://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=433214. Accessed May 17 2016.
5 European Medicines Agency (2014). Public summary of opinion of orphan designation. http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2014/09/WC500171954.pdf. Accessed May 17, 2016.
6 Van Den Bent, M et al. Efficacy of a novel antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM). Poster presentation #2542; presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, June 5, 2016.
7 Omuro, A. & DeAngelis, L. Glioblastoma and Other Malignant Gliomas: A Clinical Review. JAMA. 2013;310(17):1842-1850.
8 MacDonald, T.J., Aguilera, D., & Kramm, C.M. Treatment of high-grade glioma in children and adolescents. Neuro-Oncology. 2011; 13(10): 1049–1058.
9 American Brain Tumor Association (2014). Glioblastoma (GBM). http://www.abta.org/brain-tumor-information/types-of-tumors/glioblastoma.html. Accessed on May 17, 2016.

 

Contact(s)
AbbVie U.S. Media: Jack Hirschfield
jack.hirschfield@abbvie.com
(224) 458-0943

 

AbbVie Global Media
Dave Freundel
david.freundel@abbvie.com
(224) 358-6576

 

Investors
Liz Shea
liz.shea@abbvie.com
(847) 935-2211`

Previous Post

EC Grants Marketing Authorization for Gilead’s Epclusa for the Treatment of All Genotypes of Chronic Hepatitis C

Next Post

Bayer and X-Chem Expand Drug Discovery Collaboration to Discover Novel Medicines

Related Posts

Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows
Manufacturing

Commercial Success In New Biopharmaceutical Innovation Era

21st May 2022
Manufacturing

Proteros and AstraZeneca Boost Collaboration Agreement

18th May 2022
SEQENS Makes Multi-Million-Dollar Investment in U.S. R&D Laboratory
Middle East and South Asia

SEQENS Makes Multi-Million-Dollar Investment in U.S. R&D Laboratory

22nd March 2022
Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines
Press Statements

Exscientia and Sanofi establish strategic research collaboration to develop AI-driven pipeline of precision-engineered medicines

17th January 2022
COVID-19 Impact On Changing Pharma Research And Development
News

COVID-19 Impact On Changing Pharma Research And Development

12th January 2022
immuno-oncology therapies
Drug Development

AbbVie, University of Chicago Extend Research Collaboration to Support Preclinical Oncology Research Through 2025

19th November 2021
Next Post

Bayer and X-Chem Expand Drug Discovery Collaboration to Discover Novel Medicines

Latest News

FDA Experts Recommend Changing COVID Jab Formulation In Fall
Manufacturing

FDA Experts Recommend Changing COVID Jab Formulation In Fall

30th June 2022
Novartis to acquire The Medicines Company for USD 9.7 bn
Manufacturing

Novartis To Slash 8,000 Jobs To Save $1 Billion By 2024

30th June 2022
How Lag In African COVID-19 Jabs Slowed Its Once Rapid Pace
Manufacturing

How Lag In African COVID-19 Jabs Slowed Its Once Rapid Pace

27th June 2022
Australia Creates A Novel Stem Cell Production Technique
Manufacturing

Australia Creates A Novel Stem Cell Production Technique

27th June 2022
Novartis to acquire The Medicines Company for USD 9.7 bn
Manufacturing

Novartis Promises $250M For Tropical Illnesses, Malaria

27th June 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