Phase II data not enough for Darzalex thumbs up, says NICE

17 March 2017

The UK’s medicines cost-effectiveness body, the National Institute for Health and Care Excellence (NICE) has released a consultation document saying it cannot recommend Darzalex (daratumumab) for routine use, based on the data submitted by Janssen.

Darzalex monotherapy is being developed as a treatment for relapsed and refractory multiple myeloma, a rare kind of blood cancer, in adults.

The drug has been given breakthrough status by the US Food & Drug Administration and granted a license based on Phase II trial data. It has also been given accelerated assessment by the European Medicines Agency.

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