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


Medicines licensing

Breast cancer drug palbociclib gets expedited approval in United States

Breast cancer agent palbociclib in combination with letrozole provides 20 months of progression-free survival compared with 10 months in women taking letrozole alone.

The US Food and Drug Administration has approved palbociclib (Ibrance, Pfizer) for advanced (metastatic) breast cancer in postmenopausal women under its accelerated approval programme. In the image, micrograph of breast cancer cells

Source: Cultura RM / Alamy

Growth of breast cancer cells (pictured) is promoted by cyclin-dependent kinases (CDKs) 4 and 6, which are inhibited by palbociclib

The US Food and Drug Administration (FDA) has approved palbociclib (Ibrance; Pfizer) for advanced (metastatic) breast cancer in postmenopausal women under its accelerated approval programme.

In a statement, Pfizer said it had been in discussions with European regulatory health authorities and intends to file an application with the European Medicines Agency for a marketing authorisation for palbociclib in the EU later in 2015.

Palbociclib inhibits cyclin-dependent kinases (CDKs) 4 and 6, which promote the growth of cancer cells. It is intended for postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have not yet received an endocrine-based therapy, and is used in combination with letrozole. In a trial of 165 such women, progression-free survival was 20.2 months in women randomised to palbociclib plus letrozole, compared with 10.2 months in women who received letrozole alone.

The FDA granted palbociclib breakthrough therapy designation, because Pfizer showed the drug may offer a substantial improvement over available therapies, and it received priority review under the FDA’s accelerated programme. This programme allows approval of a drug for a serious or life-threatening disease based on data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients, allowing patients earlier access to promising drugs while the company conducts confirmatory clinical trials. The FDA’s decision on palbociclib is two months ahead of schedule; the agency was scheduled to complete its review of the application by 13 April 2015.

Palbociclib’s most common side effects are neutropenia, leukopenia, fatigue, anaemia, upper respiratory infection, nausea and vomiting, stomatitis, hair loss, diarrhoea, low blood platelet counts, decreased appetite, peripheral neuropathy, and nosebleeds. The recommended starting dose is 125 milligram for 21 days, followed by a seven-day treatment break, with complete blood count monitoring at the start of every cycle and on day 14 of the first two cycles. 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067810

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

  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • English Delftware Drug Jars

    English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Pharmaceutical Society of Great Britain.

    £54.00Buy now
  • 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
  • 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
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

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