Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Sunesis’ Voreloxin Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia

By Pharmaceutical Processing | November 5, 2009

SunesisPharmaceuticals, Inc. today announced that the U.S. Food andDrug Administration has granted voreloxin orphan drug designation for thetreatment of acute myeloid leukemia (AML). Sunesis is currently conducting twoPhase 2 clinical trials of voreloxin in AML: a single-agent study, known asREVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely tobenefit from standard induction chemotherapy and a study evaluating voreloxinin combination with cytarabine in relapsed/refractory AML. “This designation recognizes the acute need for more options in treatingthis poor-prognosis disease,” stated Steven B. Ketchum, Ph.D., Senior VicePresident of Research and Development at Sunesis. “We believe voreloxin hasthe potential to impact the standard of care for AML and we continue to beencouraged by our progress. We are finalizing a registration strategy forvoreloxin in AML and anticipate launching a pivotal trial in 2010.” Orphan drug designation is granted by the FDA Office of Orphan DrugProducts to novel drugs or biologics that treat a rare disease or conditionaffecting fewer than 200,000 patients in the U.S. The designation provideseligibility for a seven-year period of market exclusivity in the United Statesafter product approval and an exemption from user fees.

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

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
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE