Category: Asciminib

  • Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia

    Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). Scemblix (asciminib) was one of a clutch of high risk, high reward drug candidates for a range of diseases that Novartis chief executive Vas Narasimhan said last year […]

  • Novartis eyes New Year verdict from FDA on delayed Leqvio

    Novartis has revealed that the FDA has accepted its resubmission for cholesterol-lowering drug Leqvio – rejected unexpectedly by the US regulator last year – and has set a new action date of 1 January 2022. The drugmaker refiled its application for Leqvio (inclisiran) earlier this month, trying to get the programme back on track in […]

  • Novartis eyes filings for leukaemia drug asciminib after phase 3 win

    A first-in-class STAMP inhibitor developed by Novartis – asciminib – has outperformed a current drug for chronic myeloid leukaemia (CML) in a head-to-head trial, setting up regulatory filings. The ASCEMBL trial compared asciminib (ABL001) to Pfizer’s Bosulif (bosutinib) in Philadelphia chromosome-positive CML patients who had previously been treated with two or more tyrosine kinase inhibitors […]