Janssen landed conditional approval in Europe for its Darzalex drug as a monotherapy for treating relapsed and refractory multiple myeloma in adults.
Janssen noted that the conditional approval was under an accelerated assessment and based on data from several studies. The studies showed that 83 percent of patients achieved results of disease stability or better.
The European Commission decision also follows a positive opinion from the EMA’s European Committee for Medicinal Products for Human Use. The decision enables Janssen to market Darzalex in all 28 EU member states and the three European Economic Area countries of the European Union.