Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

Breast cancer

FDA approves drug to reduce risk of HER2-positive breast cancer returning

Micrograph of HER2-positive breast cancer


The US Food and Drug Administration has approved neratinib (Nerlynx; Puma Biotechnology), a kinase inhibitor that blocks enzymes that promote cell growth, for early-stage, HER2-positive breast cancer

The US Food and Drug Administration (FDA) has approved neratinib (Nerlynx; Puma Biotechnology) as the first extended adjuvant therapy for early-stage, HER2-positive breast cancer.

Neratinib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It is a form of therapy that is taken after initial treatment to further lower the risk of the cancer coming back. It is indicated for adult patients who have been previously treated with trastuzumab (Herceptin; Genentech).

Richard Pazdur, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products within the FDA’s Center for Drug Evaluation and Research, said: “HER2-positive breast cancers are aggressive tumours and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan.”

“Now, these patients have an option after initial treatment that may help keep the cancer from coming back,” he added.

The safety and efficacy of neratinib was studied in a randomised control trial involving 2,840 patients with early-stage, HER2-positive breast cancer who had been treated with a regimen of trastuzumab in the last two years. Researchers measured the amount of time after the trial that it took for the cancer to come back or for death to occur. After two years, 94.2% of patients had not experienced recurrence or death, compared with 91.9% of patients who had received placebo.

Common side effects included diarrhoea, nausea, abdominal pain and fatigue.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203217

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Paediatric Drug Handling

    Paediatric Drug Handling

    Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication.

    £33.00Buy now
  • Physicochemical Principles of Pharmacy

    Physicochemical Principles of Pharmacy

    This established textbook covers every aspect of drug properties from the design of dosage forms to their delivery by all routes to sites of action in the body.

    £48.00Buy now
  • Prescribing Medicines for Children

    Prescribing Medicines for Children

    Prescribing Medicines for Children is designed to improve understanding on all aspects of paediatric prescribing, from the development of suitable drugs through to their practical administration.

    £60.00Buy now
  • Introduction to Renal Therapeutics

    Introduction to Renal Therapeutics

    Introduction to Renal Therapeutics covers all aspects of drug use in renal failure. Shows the role of the pharmacist in patient care for chronic kidney disease.

    £38.00Buy now
  • FASTtrack: Pharmacology

    FASTtrack: Pharmacology

    FASTtrack: Pharmacology is a study guide providing an account of drug action, as well as dealing with molecular pharmacology at a more advanced level.

    £25.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • Micrograph of HER2-positive breast cancer

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.