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Janssen receives new breakthrough designation for cancer drug
Janssen has announced that its innovative oral Bruton's tyrosine kinase (BTK) inhibitor therapy ibrutinib has received a third breakthrough therapy designation from the US Food and Drug Administration (FDA).
The US regulator has granted this label to Janssen's investigational drug due to its potential as a monotherapy for patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma with deletion of the short arm of chromosome 17 (del17p).
This genetic mutation is associated with poor prognoses for patients affected by these cancer types.
It comes after the FDA previously gave ibrutinib breakthrough therapy designations for relapsed or refractory mantle cell lymphoma and Waldenstrom's macroglobulinaemia earlier this year.
Dr Peter Lebowitz, global oncology therapeutic area head at Janssen, said: "Ibrutinib continues to demonstrate promise for patients living with B-cell malignancies and we are pleased that the FDA has recognised its potential for people living with CLL and the del17p mutation."
Last month, Janssen revealed that it will be working together with Cancer Research Technology to carry out studies into new treatments for multiple myeloma.
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