Oncophage: Withdrawal of the marketing authorisation application

Oncophage is a solution for injection that contains the active substance vitespen (20 micrograms).

Oncophage was expected to be used in patients with renal cell carcinoma (a type of kidney cancer) that had not yet spread to other parts of the body (localised). It was to be used when there is a high risk of the cancer coming back after the patient has had surgery to remove the tumour.

Oncophage was designated as an 'orphan medicine' (a medicine to be used in rare diseases) on 11 April 2005 for renal cell carcinoma.

Oncophage is an autologous immunotherapy product. Autologous means that it is derived from the cells in the patient's own body. The active substance in oncophage, vitespen, is made up of proteins ('heat shock protein-peptide complex-96') that have been extracted from the patient's cancer cells. When Oncophage is given to the patient, the body's defence system (immune system) learns to recognize the proteins in vitespen as foreign and triggers an immune response. Since the proteins in vitespen are similar to proteins on the cancer cells, it was expected that the immune system would also attack the cancer cells, preventing the recurrence or the spread of the original tumour.

The effects of Oncophage were first tested in experimental models before being studied in humans. The company presented results of a study involving 818 adults with localised renal cell carcinoma that had been surgically removed and who had a high risk of the cancer coming back. The study compared the patients who were given Oncophage with those who were not. The main measure of effectiveness was how long the patients lived without the cancer coming back.

The evaluation had finished and the CHMP had given a negative opinion. The company withdrew before the European Commission had issued a decision on this opinion.

Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Oncophage for use as an add-on treatment after surgery for localised renal cell carcinoma at high risk of coming back.

The CHMP was of the opinion that the main study did not show that Oncophage was effective at prolonging the length patients lived without the cancer coming back. The Commitee also noted that the company had provided insufficient information on the contents of the medicine and on the manufacturing process. There was also not enough information to clarify the way Oncophage works in renal cell carcinoma and to determine the appropriate dose of the medicine.

Therefore, at that point in time, the CHMP was of the opinion that the benefits of Oncophage did not outweigh its risks.

The letter from the company notifying the Agency of the withdrawal of the application are available under the tab 'All documents'.

The company informed the CHMP that there are no patients in the European Union currently receiving Oncophage as part of a clinical trial or a formal compassionate use or named patient programme.