pharmaphorum March 20, 2024
Takeda’s Iclusig has become the first targeted therapy approved by the FDA for use alongside chemotherapy as a first-line therapy for a rare form of acute lymphoblastic leukaemia (ALL).
The US regulator has cleared Iclusig (ponatinib) with reduced-intensity chemo for adult patients with newly diagnosed Philadelphia chromosome-positive ALL (Ph+ ALL), a fast-progressing blood cancer that makes up around a quarter of adult ALL cases.
It occurs when pieces of chromosomes 9 and 22 switch with each other to form abnormal structures and the development of the BCR-ABL1 kinase, which is targeted by Iclusig.
The accelerated approval draws on data from the PhALLCON trial, which compared Iclusig to imatinib – sold by Novartis as Glivec/Gleevec, but also available as a generic...
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