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FDA approved nilotinib for paediatric patients with newly diagnosed Ph+ CML-CP or Ph+ CML-CP resistant or intolerant to prior TKI

 

  • FDA approved nilotinib (TASIGNA, Novartis Pharmaceuticals Corporation) for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. More Information.  March 22, 2018

Bosutinib FDA approved for the treatment of patients with newly-diagnosed chronic phase Ph+ CML

On 19 December 2017, the FDA granted accelerated approval to bosutinib (Bosulif®, Pfizer) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML).

Ribociclib FDA label updated to include pre- and perimenopausal women

Dasatinib FDA approved in paediatric patients with chronic phase Ph+ CML

On 9 November 2017, the FDA granted regular approval to dasatinib (Sprycel®, Bristol-Myers Squibb) for the treatment of paediatric patients with chronic phase (CP) Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML).

Ribociclib FDA label updated to include pre- and perimenopausal women