Good news not to be missed: Is bosutinib on the market?

Bosutinib (Bosutinib) was first approved by the U.S. Food and Drug Administration (FDA) in 2012 for the treatment of chronic, accelerated, or blast phasePh+CML in adults who are resistant or intolerant to previous treatments. In September 2023, bosutinib was also approved by the FDA for the treatment of CML in children who are newly diagnosed or who are resistant/intolerant to previous treatments. The approval is based on favorable results from the open-label, randomized, multicenter trial BFORE, which demonstrated a significant improvement in major molecular response to bosutinib treatment, defined internationally as a BCR ABL ratio of ≤0.1%.

The primary efficacy outcome measures include major cytogenetic response (MCyR), complete cytogenetic response (CCyR) and major molecular response (MMR). For pediatric patients with ND CP Ph+CML, major (MCyR) and complete (CCyR) cytogenetic responses were 76.2% and 71.4%, respectively. The MMR was 28.6%, and the median follow-up time was 14.2 months. For pediatric patients with R/I CP Ph+ CML, major (MCyR) and complete (CCyR) cytogenetic responses were 82.1% and 78.6%, respectively. The maternal mortality rate is 50%.

The originator drug of bosutinib is not marketed in the country, so it cannot be included in medical insurance. Currently, the original drugs sold overseas include Turkish version and European version. The price of the Turkish version may be more than RMB 2,000 per box of 500mg*28, and the price of the European version may be more than RMB 30,000 (the price may fluctuate due to the exchange rate). There are also bosutinib generic drugs produced overseas in other countries. Their pharmaceutical ingredients are basically the same as those of the original drug. The price of 500mg*30 per box may be more than 2,000 yuan (the price may fluctuate due to the exchange rate), and the price is relatively cheap.