Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA Approves Onyx Blood Cancer Drug Kyprolis

By Pharmaceutical Processing | July 23, 2012

WASHINGTON (AP) — The FDA has approved a new blood cancer drug from Onyx Pharmaceuticals Inc. for patients with advanced disease who have not responded to at least two other drugs.

The injectable drug Kyprolis treats multiple myeloma, a form of cancer that causes tumors to grow in the bone marrow, preventing the production of normal blood cells. Patients with the disease have low red blood cell counts and are more likely to experience infections and excessive bleeding.

The FDA approved the drug for patients who have already tried at least two other drugs, including Velcade and various drugs that boost the immune system.

Shares of South San Francisco, Calif.-based Onyx Pharmaceuticals rose $6.34, or 9.3 percent, to $74.74.

The company studied the drug in 266 patients with advanced multiple myeloma who had already been treated with Velcade and thalidomide. About 23 percent of patients experienced a full or partial disappearance of their tumors, with the typical effect lasting about 7.8 months.

Thirty percent of patients experienced side effects from the drug, including fatigue, fever, shortness of breath and diarrhea.

About 21,700 people will be diagnosed with multiple myeloma this year and 10,710 will die from the disease, according to the American Cancer Society.

The drug was approved under the FDA’s accelerated approval program, which allows the agency to clear drugs based on promising preliminary data. Drug companies have to submit follow-up studies showing that the drug performed as expected.

 

 

Related Articles Read More >

FDA logo
Ultra Supplement announces recall for undeclared tadalafil
analyzing medical sample
Expert answers to nitrosamine impurity questions
Cardinal Health
Cardinal Health announces $124M settlement of investors’ opioid suit
FDA logo
FDA warns four companies over selling honey tainted with prescription drugs

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.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 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
  • R&D 100 Awards