Im­bru­vi­ca reg­i­men wins FDA ap­proval as first non-chemother­a­py treat­ment for un­treat­ed pa­tients with com­mon form of leukemia

In the 10th ap­proval since its 2013 launch, J&J’s can­cer drug Im­bru­vi­ca has se­cured the FDA nod in com­bi­na­tion with Roche’s obin­u­tuzum­ab in adults with the most com­mon form of leukemia — mark­ing the first non-chemother­a­py reg­i­men for treat­ment-naïve pa­tients with chron­ic lym­pho­cyt­ic leukemia/small lym­pho­cyt­ic lym­phoma (CLL/SLL).

The ap­proval ex­pands the use of Im­bru­vi­ca — which is al­so sold by Ab­b­Vie — in front­line CLL/SLL be­yond its use as a monother­a­py. The drug it­self gen­er­at­ed sales of about $2.6 bil­lion last year. The block­buster treat­ment has seen steady growth in mar­ket share, lead­ing the Unit­ed States in first and sec­ond line CLL as well as sec­ond-line man­tle cell lym­phoma (MCL), and is the to­tal pa­tient share leader in Walden­strom macroglob­u­line­mia (WM) — a type of non-Hodgkin lym­phoma — ac­cord­ing to Cred­it Su­isse.

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