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Ixazomib (Ninlaro) has received a negative recommendation from the Committee for Human Medicinal Products (CHMP) within the European Medicines Agency.

The CHMP is responsible for developing recommendations for the European Commission on new medicines going through the European marketing authorisation process. It assesses and makes recommendations on whether a drug is safe and effective enough to be granted a marketing authorisation for use across the European Union. Usually the European Commission follows the advice of the CHMP. This would mean that ixazomib will not receive European marketing authorisation, and doctors will be unable to routinely prescribe it for their patients.

Ixazomib belongs to a group of treatments known as proteasome inhibitors. It is a similar drug to Velcade® (bortezomib) and Kyprolis® (carfilzomib), however if approved, ixazomib would become the first oral proteasome inhibitor to receive a European licence.

The licence application is based on data from a Phase III clinical trial known as the Tourmaline-MM1 which compared ixazomib in combination with Revlimid® and dexamethasone, to Revlimid and dexamethasone alone in relapsed and/or refractory myeloma patients. The clinical trial results to-date show that ixazomib is safe and effective in the treatment of relapsed and/or refractory myeloma.

The CHMP recommendation does not affect any of the ongoing trials or compassionate use programmes of ixazomib.

The full EMA decision can be read here http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003844/WC500207384.pdf

 

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