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Withdrawal of Application for the EU Marketing Authorisation of Erlotinib Accord

It was intended for the treatment of non-small-cell lung cancer and pancreatic cancer
15 Jun 2020
Anticancer agents & Biologic therapy;  Gastrointestinal cancers;  Lung and other thoracic tumours

On 28 May 2020, the European Medicines Agency (EMA) has informed that the Accord Healthcare S.L.U. withdrew its application for a marketing authorisation of Erlotinib Accord (erlotinib) for the treatment of non-small-cell lung cancer (NSCLC) and pancreatic cancer. The company withdrew the application on 11 May 2020.

Erlotinib Accord was developed as a medicine for advanced or metastatic NSCLC. It was intended mainly for use in patients whose cancer cells have EGFR activating mutations. Erlotinib Accord was also intended for use in treating locally advanced or metastatic cancer of the pancreas, in combination with gemcitabine.

Erlotinib Accord contains the active substance erlotinib and was to be available as tablets to be taken by mouth.

Erlotinib Accord was developed as a generic medicine. This means that Erlotinib Accord contained the same active substance as an authorised reference medicine Tarceva and was intended to work in the same way.

The active substance in Erlotinib Accord and Tarceva, erlotinib, works by blocking EGFRs, which are present on the cells of certain cancers.

Studies on the benefits and risks of the active substance are not needed for a generic medicine because they have already been carried out with the reference medicine.

As for every medicine, the company provided studies on the quality of Erlotinib Accord. The company also provided a study to investigate whether Erlotinib Accord is bioequivalent to the reference medicine Tarceva. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

The application was withdrawn after the EMA had evaluated the information from the company and prepared questions for the company. After the Agency had assessed the company’s responses to the last round of questions, there were still some unresolved issues.

Based on the review of the data and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some concerns and its provisional opinion was that Erlotinib Accord could not have been authorised for the treatment of NSCLC and pancreatic cancer.

The Agency’s concerns related to the way the study on bioequivalence had been carried out following an inspection for Good Clinical Practice. The inspection raised a number of concerns including the ways in which the study had been set up, supervised and modified and how the data from the study were recorded and managed.

Therefore, at the time of the withdrawal, the Agency’s opinion was that the results of the study were not reliable and that the medicine could not have been authorised based on the data from the company.

In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its marketing application because the bioequivalence data from the study were not considered adequate.

The company informed the Agency that there are no consequences for patients in clinical trials using Erlotinib Accord.

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