The European Medicines Agency has recommended the refusal of the marketing authorisation for Turalio, a medicine intended for the treatment of tenosynovial giant cell tumour from Plexxicon/Daiichi Sankyo.
The Agency was concerned that although the main study found that tumours shrank in patients treated with Turalio, there was only a small improvement in symptoms such as pain and the ability to use the joint. It was not clear how long this effect lasts. There was also serious concern about unpredictable, potentially life-threatening effects of Turalio on the liver. Therefore, the Agency’s opinion was that the benefits of Turalio did not outweigh its risks and it recommended refusing marketing authorisation.