Or­chard halts dos­ing of EMA-ap­proved Strimvelis af­ter pa­tient de­vel­ops leukemia

Or­chard Ther­a­peu­tics is pulling its EMA-ap­proved gene ther­a­py Strimvelis off the shelves while it in­ves­ti­gates a po­ten­tial link be­tween the drug and a case of lym­phoid T-cell leukemia.

The biotech $OR­TX said it was no­ti­fied of the ad­verse event a few days ago — just months af­ter it slashed 25% of its work­force in an at­tempt to stray away from rare dis­eases like “bub­ble boy syn­drome,” the one Strimvelis is ap­proved for. The pa­tient was treat­ed un­der a com­pas­sion­ate use pro­gram in 2016, and is now be­ing treat­ed for leukemia at a spe­cial­ty cen­ter. Pre­lim­i­nary find­ings sug­gest the di­ag­no­sis could be linked to an in­ser­tion­al event re­lat­ed to the treat­ment, Or­chard an­nounced.

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