Withdrawal of the EU Marketing Authorisation Application for Binimetinib

It was expected to be used for treating advanced melanoma patients with NRAS Q61 mutation

On 4 January 2018, Pierre Fabre Médicament officially notified the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for binimetinib (Balimek), for the treatment of melanoma. 

Balimek is a medicine that contains the active substance binimetinib. It was to be available as tablets. 

Balimek was expected to be used for treating melanoma that had spread or could not be removed by surgery. It was to be used in patients who have the NRAS Q61 mutation. 

The active substance in Balimek, binimetinib, blocks MEK1 and MEK2. These proteins encourage the growth of new cells. By blocking the MEK proteins, Balimek is expected to slow down the growth of melanoma cells. 

The company presented data from one main study comparing Balimek with dacarbazine. The study involved 402 patients with advanced melanoma with the NRAS Q61 mutation whose tumour had spread or could not be removed by surgery. The main measure of effectiveness was 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The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.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 data reviewed, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Balimek could not have been approved for the treatment of advanced melanoma in patients with the NRAS Q61 mutation. 

The CHMP noted that patients treated with Balimek had slightly longer progression-free survival compared with those receiving dacarbazine. Considering this, along with data on overall survival and quality of life, the CHMP considered that Balimek's effectiveness was questionable. Moreover, the CHMP was concerned that Balimek was linked to worse side effects than dacarbazine. 

The CHMP also considered that although no medicine is approved specifically to treat patients with the NRAS Q61 mutation, there are effective treatments for melanoma in general. The evidence provided was insufficient to show that Balimek fulfils an unmet medical need. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Balimek did not outweigh its risks. 

In its letter notifying the EMA of the withdrawal of the application, the company stated that the withdrawal is based on CHMP’s opinion that the data supplied did not provide sufficient evidence to conclude that the medicine’s benefits outweigh its risks. 

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