1 5 , ▁the ▁U . S . ▁Food ▁and ▁D rug ▁Administration ▁( F DA ) ▁granted ▁i x az om ib ▁combined ▁with ▁len al id om ide ▁and ▁de x am eth as one ▁a ▁priority ▁review ▁design ation ▁for ▁multiple ▁my el oma . ▁On ▁ 2 0 ▁November ▁ 2 0 1 5 , ▁the ▁F DA ▁approved ▁this ▁combination ▁for ▁second - line ▁treatment . ▁ ▁The ▁request ▁for ▁market ing ▁author isation ▁in ▁Europe ▁was ▁initially ▁refused ▁by ▁the ▁European ▁Medic ines ▁Agency ▁( EMA ) ▁in ▁May ▁ 2 0 1 6 ▁due ▁to ▁ins u fficient ▁data ▁showing ▁a ▁benefit ▁of ▁treatment . ▁After ▁Tak eda ▁requested ▁a ▁re - ex am ination , ▁the ▁E MA ▁granted ▁a ▁market ing ▁author isation ▁on ▁ 2 1 ▁November ▁ 2 0 1 6 ▁on ▁the ▁condition ▁that ▁further ▁effic acy ▁studies ▁be ▁conducted . ▁The ▁appro val ▁indic ation ▁is ▁the ▁same ▁as ▁in ▁the ▁US . ▁ ▁Research ▁, ▁i x az om ib ▁is ▁also ▁in ▁Ph ase ▁III ▁clin ical ▁tri als ▁for ▁the ▁treatment ▁of ▁AL ▁am y lo idos is ▁and ▁pl as mac yt oma ▁of ▁the ▁b ones , ▁and ▁in ▁Ph ase ▁I / II ▁tri als ▁for ▁various ▁other ▁conditions . ▁ ▁References ▁▁ ▁Category : B or onic ▁ac ids ▁Category : Pro te as ome ▁in hib itors ▁Category : Or phan ▁dru gs ▁Category : T ak eda ▁Ph arma ce ut