Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Onyx Pharmaceuticals Announces Positive Top-Line Carfilzomib Data From Phase 2b Study

July 26, 2010 By Bio-Medicine.Org

EMERYVILLE, Calif., July 26 /PRNewswire-FirstCall/ — Onyx
Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced positive top-line results
from the Phase 2b 003-A1 study of single-agent carfilzomib, a
selective, next generation proteasome inhibitor, in patients with
relapsed and refractory multiple myeloma.  In an independent
review of the data, carfilzomib achieved an overall response rate
(partial response or greater) of 24 percent and a median duration
of response of 7.4 months in patients who entered the study after
receiving a median of five prior lines of therapy (corresponding to
a median of 13 anti-myeloma agents) and whose disease was
refractory to their last therapeutic regimen. The clinical benefit
rate (minimal response or greater) in the study population was 36
percent.  Carfilzomib was well-tolerated and there were no new
or unexpected toxicities observed.  Full results of the trial
will be presented at an upcoming scientific meeting.  Based on
these results, Onyx is continuing discussions with the U.S. Food
and Drug Administration (FDA) regarding next steps in filing a new
drug application (NDA) for carfilzomib, which the company expects
to submit by year-end 2010 for potential accelerated approval in
the U.S.

“Despite recent advances in treating multiple myeloma, all
patients eventually relapse. The unmet medical need remains great,
as the outlook for patients with relapsed and refractory disease is
grim,” said Michael G. Kauffman,
M.D., Ph.D., Chief Medical Officer of Onyx Pharmaceuticals.
“According to a study from the International Myeloma Working Group,
patients, such as those enrolled in the 003-A1 study, can expect to
respond to therapy only 11 percent of the time and survive f

‘/>”/>

SOURCE

Related Articles Read More >

An image of Abbott's Infinity deep brain stimulation (DBS) implants and leads.
How Abbott developed the first-of-its-kind Infinity DBS system
Axoft Fleuron brain-computer interface BCI probe
Axoft makes Fleuron BCI material available for purchase, inks license deal with Stanford
An illustration showing the Edwards Lifesciences Sapien M3 transcatheter mitral valve replacement (TMVR) system's valve being placed in the heart. [Image courtesy of Edwards Lifesciences]
The top nitinol cardiac medtech news of 2025 (so far)
An illustration showing the Edwards Lifesciences Sapien M3 transcatheter mitral valve replacement (TMVR) system's valve being placed in the heart. [Image courtesy of Edwards Lifesciences]
Q&A with Darshin Patel, who led the Edwards Lifesciences Sapien M3 TMVR system’s development
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe