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Withdrawal of the Marketing Authorisation Application for Cediranib

It was intended for the treatment of ovarian cancer
18 Oct 2016
Gynaecologic malignancies;  Anticancer agents & Biologic therapy

On 19 September 2016, AstraZeneca AB officially notified the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for cediranib (Zemfirza), for the treatment of ovarian cancer.

What is Zemfirza?

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

What was Zemfirza expected to be used for?

Zemfirza was expected to be used to treat women with cancer of the ovaries, including cancer of the fallopian tubes and cancer of the peritoneum. It was to be used in patients whose disease had come back after previous treatment.

Zemfirza was designated an orphan medicine on 29 July 2014 for treatment of ovarian cancer.

How does Zemfirza work?

The active substance in Zemfirza, cediranib, blocks the activity of vascular endothelial growth factor (VEGF) receptors. 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.

What did the company present to support its application?

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 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 progression-free survival.

How far into the evaluation was the application when it was withdrawn?

The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.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.

What was the recommendation of the CHMP at that time?

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.

What were the reasons given by the company for withdrawing the application?

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.

What consequences does this withdrawal have for patients in clinical trials?

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

Last update: 18 Oct 2016

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