Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

EMA Adopts a Negative Opinion for Extension of Indications for Sunitinib

It was expected to use sunitinib to delay or prevent the recurrence of renal cell carcinoma in patients who have had surgery and are at high risk for relapse
27 Feb 2018
Genitourinary cancers;  Anticancer agents & Biologic therapy

On 22 February 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product sunitinib (Sutent). The change concerned an extension of indication in patients at high risk of renal cell carcinoma recurrence after surgery. 

The company that applied for the change to the authorisation is Pfizer Limited. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion. 

Sutent is a cancer medicine currently authorised in EU for treating the following cancers: 

  • gastrointestinal stromal tumour 
  • pancreatic neuroendocrine tumours 
  • metastatic renal cell carcinoma.

Sutent was expected to be used to delay or prevent the recurrence of renal cell carcinoma in patients who have had surgery and are at high risk for relapse. 

The active substance in Sutent, sunitinib, is a protein kinase inhibitor. It blocks specific enzymes known as protein kinases involved in the growth and spread of cancer cells and the development of new blood vessels. By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing. 

The company presented results of a main study comparing Sutent with placebo in 615 patients at high risk for renal cell carcinoma recurrence after surgery. Patients were treated for around a year and the study looked at disease-free survival. 

The CHMP considered that the evidence that Sutent delays the cancer recurrence was not convincing. When data from those patients at highest risk of relapse were looked separately, the benefits of Sutent were still not convincing. Given the known side effects of the medicine, the Committee concluded that the benefits did not outweigh the risks and recommended that the change to the marketing authorisation of Sutent be refused. 

The company informed the CHMP that the negative opinion does not have any consequences for patients currently included in clinical trials with Sutent. There are no ongoing clinical trials with Sutent being used for cancer treatment after surgery and no compassionate use programmes with Sutent in Europe.

Last update: 27 Feb 2018

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.