EMA Recommends Conditional Approval for Daratumumab

The European Medicines Agency (EMA) has recommended the approval of daratumumab for adult patients with multiple myeloma who have already failed standard treatment. This type of conditional approval is given to drugs that provide an unmet medical need for severe conditions and reveal early evidence of benefits outweighing the risks.

The EMA’s Committee for Medicinal Products for Human Use is still evaluating data from two ongoing studies before granting approval. These data are expected to be available by late 2017.

Daratumumab is already approved in the United States for adult MM patients who have failed at least three prior therapies.

Source: Janssen press release, April 3, 2016.