Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

FDA Clears Clinical Studies To Evaluate Tabelecleucel In Epstein-Barr Virus Therapy

December 29, 2017 By Atara Biotherapeutics, Inc.

Atara Biotherapeutics, Inc., an off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune, and viral diseases, today announced that it received clearance from the U.S. Food and Drug Administration (FDA) to initiate two Phase 3 clinical studies with tabelecleucel (formerly known as ATA129) in patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD).

The company plans to initiate these studies imminently. Tabelecleucel is Atara’s off-the-shelf T-cell immunotherapy in development for the treatment of EBV+PTLD, as well as other EBV associated hematologic and solid tumors.

Atara’s tabelecleucel Phase 3 program consists of two global, multicenter, open-label studies:

  • for the treatment of patients with EBV+PTLD following allogeneic hematopoietic cell transplant (HCT) after failure of rituximab (MATCH), and
  • for patients with EBV+PTLD following solid organ transplant (SOT) after failure of rituximab or after failure of rituximab plus chemotherapy (ALLELE).

The Phase 3 studies are expected to open for enrollment in the U.S. imminently and will later expand to include sites in the EU, Canada, and Australia.

Results from the first tabelecleucel Phase 3 study to reach the primary endpoint are expected to be announced in the first half of 2019. Atara also plans to submit a tabelecleucel Conditional Marketing Authorization (CMA) application in the EU for patients with rituximab-refractory EBV+PTLD following HCT during the first half of 2019. In addition, Atara plans to continue working with the FDA, Health Canada, and other global health authorities to make tabelecleucel available to patients as expeditiously as possible.

(Source: Atara Biotherapeutics, Inc.)

Related Articles Read More >

Logos of Creo Medical and Intuitive
Creo Medical inks collaboration agreement with Intuitive
Lazurite ArthroFree wireless surgical camera system Minnetronix Medical
How Minnetronix Medical helped Lazurite with its wireless surgical camera
Medtronic Hugo robot-assisted surgery system
The road to a robot: Medtronic’s development process for its Hugo RAS system
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
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

Enewsletter Subscriptions

Enewsletter Subscriptions

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
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • 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 E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. 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
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech