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

FDA speeds up approval for rare cancer drug

Regulators in the United States have approved immunotherapy drug avelumab (Bavencio; Pfizer and Merck KGaA) for the treatment of a rare aggressive skin cancer under an accelerated evaluation process.

It is the first treatment to be approved for metastatic Merkel cell carcinoma (MCC) by the US Food and Drug Administration (FDA), which is responsible for evaluating the safety and efficacy of medicines in the United States.

Around half of the 1,600 patients diagnosed with MCC in the United States each year experience recurrence after surgery, with 30% going on to develop metastatic disease.

Avelumab, which is being trialled in a number of cancer types, is a monoclonal antibody that blocks the PD-1/PD-L1 pathway, which is thought to help activate parts of the immune system, including T-cells to attack cancer cells.

The FDA based the accelerated approval on a single-arm trial of 88 patients with metastatic MCC who had previously received chemotherapy with a different drug. It was reported that 33% of patients receiving the drug had partial or complete tumour shrinkage. For those patients, 86% had a response lasting more than six months and 45% had a response lasting more than a year.

The regulator says that avelumab should be used for patients aged 12 years or over with no need for prior chemotherapy.

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, says: “The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies — even in rare forms of cancer where treatment options are limited or non-existent.”

The FDA’s accelerated approval process is used to evaluate drugs intended for serious conditions and which fill an unmet medical need.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202510

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

  • US FDA building and signage

Jobs you might like

Newsletter Sign-up

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