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

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.