Zemfirza: Withdrawal of the marketing authorisation application

Zemfirza is a cancer medicine that contains the active substance cediranib. It was to be available as tablets.

Zemfirza was expected to be used to treat women with cancer of the ovaries, including cancer of the fallopian tubes that connect the ovaries to the womb and cancer of the peritoneum (the membrane lining the abdomen). It was to be used in patients whose disease had come back after previous treatment.

Zemfirza was designated an 'orphan medicine' (a medicine to be used in rare diseases) on 29 July 2014 for treatment of ovarian cancer.

The active substance in Zemfirza, cediranib, blocks the activity of 'vascular endothelial growth factor' (VEGF) receptors. These receptors are found in high amounts on blood vessel cells and are involved in the development of new blood vessels that supply nutrients to cancer cells. By blocking VEGF receptors, this medicine is expected to reduce blood supply to the cancer cells, thus slowing down the growth and spread of the cancer.

The company presented the results of one main study involving 456 patients with ovarian cancer that had come back 6 months or more after one previous treatment with platinum-based medicine. In the study, Zemfirza was compared with placebo (a dummy treatment) and was given together with platinum-based medicines during initial treatment and subsequently on its own during a maintenance period. The main measure of effectiveness was the length of time patients lived without their disease getting worse (progression-free survival).

The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions. The company had not responded to the last round of questions at the time of the withdrawal.

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 some concerns and was of the provisional opinion that Zemfirza could not have been approved for the treatment of ovarian cancer.

The CHMP was concerned about the reliability of the study results following a routine inspection at the clinical study sites which revealed that the study had not been conducted in full compliance with Good Clinical Practice (GCP). In addition, the observed improvement in progression-free survival with Zemfirza was considered modest and there were concerns regarding the medicine's side effects, particularly diarrhoea and tiredness, which led to many patients stopping treatment early.

Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zemfirza had not been shown to outweigh its risks and had requested further clarification from the company.

In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of the questions still remaining at this late stage of the review.

The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Zemfirza.

If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.