Bosutinib

Novartis secures FDA accelerated approval for Scemblix (asciminib) as first-line therapy for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML-CP), expanding eligible patient population fourfold. Scemblix demonstrated superior major molecular response (MMR) and deep molecular response (DMR) rates compared to existing tyrosine kinase inhibitors (TKIs) in the ASC4FIRST trial, with a favorable safety profile. Novartis anticipates rapid market access and global expansion, aiming for a potential $3 billion annual sales.

FDA approved Scemblix for newly diagnosed chronic myeloid leukemia, based on ASC4FIRST trial showing 68% major molecular response rate at 48 weeks vs. 49% with tyrosine kinase inhibitors. Common side effects include rash, musculoskeletal pain, and upper respiratory tract infection.

Patients with CML benefit from timely initiation, appropriate dosing, and potential treatment discontinuation with TKIs like bosutinib, which showed 81.1% achieving or sustaining CCyR in the BYOND trial. Ongoing research aims to identify novel agents offering deeper, longer-lasting responses without compromising safety or increasing costs. Bosutinib's safety profile, particularly its low cardiovascular AEs, differentiates it from other TKIs, making it a preferred option for long-term use.