As­traZeneca scores again: Calquence ap­proved for CLL as BTK race heats up

Six months af­ter first boast­ing about Phase III da­ta, As­traZeneca has earned ex­pand­ed FDA ap­proval for its BTK in­hibitor Calquence. The drug will now be used to treat one of the most com­mon adult blood can­cers, chron­ic lym­pho­cyt­ic leukemia (CLL).

In the spring, the Eu­ro­pean gi­ant called its shot ear­ly, point­ing to­ward reg­u­la­to­ry sub­mis­sions as in­ter­im tri­al da­ta came out. They said in May the drug had aced a Phase III tri­al as a sec­ond-line CLL treat­ment. Then in June, they an­nounced high pro­gres­sion-free sur­vival from pa­tients in a tri­al of pa­tients who re­ceived Calquence as a front­line ther­a­py.

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