Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

FDA Grants Breakthrough Designation for Multiple Myeloma Drug

Published: Tuesday, May 20, 2014
Last Updated: Tuesday, May 20, 2014
Bookmark and Share
Bristol-Myers Squibb and AbbVie received the designation for Elotuzumab, an investigational humanized monoclonal antibody for multiple myeloma.

Bristol-Myers Squibb Company and AbbVie announce that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. The designation is based on findings from a randomized Phase 2, open-label study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated patients, including the 10 mg/kg dose that is being studied in Phase 3 trials. Data from the Phase 2 trial were most recently presented at the 18th Annual Congress of the European Hematology Association (EHA) in 2013.

According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

“Despite recent advances in the treatment of relapsed or refractory multiple myeloma, it remains an area of unmet need,” said Michael Giordano, senior vice president, Head of Development, Oncology & Immunosciences, Bristol-Myers Squibb. “This Breakthrough Therapy Designation underscores the potential of elotuzumab in this setting and reinforces Bristol-Myers Squibb’s longstanding commitment to the research and development of novel medicines to treat hematologic malignancies.”


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,400+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

BMS Partners with Medical University
The Medical University of South Carolina and Bristol-Myers Squibb Company have announced that they have entered into a collaboration focused on fibrotic diseases, including scleroderma, renal fibrosis and idiopathic pulmonary fibrosis.
Thursday, July 16, 2015
Bristol-Myers Squibb and Calibr Collaborate
Collaboration and license agreement focused on new treatment approaches for fibrotic diseases.
Thursday, January 08, 2015
U.S. FDA Approves DVT Drug Eliquis®
The approval gives U.S. orthopedic surgeons a new option for DVT prophylaxis in both hip and knee replacement surgery.
Monday, March 17, 2014
Scientific News
RNAi Screening Trends
Understand current trends and learn which application areas are expected to gain in popularity over the next few years.
Long-sought Discovery Fills in Missing Details of Cell 'Switchboard'
A biomedical breakthrough reveals never-before-seen details of the human body’s cellular switchboard that regulates sensory and hormonal responses.
Tracking Breast Cancer Before it Grows
A team of scientists led by University of Saskatchewan researcher Saroj Kumar is using cutting-edge Canadian Light Source techniques to screen and treat breast cancer at its earliest changes.
Zebrafish Reveal Drugs that may Improve Bone Marrow Transplant
Compounds boost stem cell engraftment; could allow more matches for patients with cancer and blood diseases.
DNA Damage Seen in Patients Undergoing CT Scanning
Along with the burgeoning use of advanced medical imaging tests over the past decade have come rising public health concerns about possible links between low-dose radiation and cancer.
The Light of Fireflies for Medical Diagnostics
EPFL scientists have exploited the light of fireflies in a new method that detects biological molecules without the need for complex devices and high costs.
Vital Protein in Healthy Fertilization Process Identified
Researchers at the National Institutes of Health have discovered a protein that plays a vital role in healthy egg-sperm union in mice.
Teeth Reveal Lifetime Exposures to Metals, Toxins
Researchers have identified dental biomarkers to reveal links between early iron exposure and late life brain diseases.
Simple Technology Makes CRISPR Gene Editing Cheaper
University of California, Berkeley, researchers have discovered a much cheaper and easier way to target a hot new gene editing tool, CRISPR-Cas9, to cut or label DNA.
Could a simple saliva test detect Alzheimer's?
Researchers have presented findings suggesting that a simple, non-invasive diagnostic for Alzheimer's could be within reach.
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!