Mylotarg is the world's first approved antibody conjugate drug, which has undergone a unique process of delisting and re approval during its marketing process, and has significant milestone significance in cancer treatment.

1. First global approval

(1) First time on the market: Obtained accelerated approval from the US FDA in May 2000 for CD33 positive acute myeloid leukemia

(2) Indications: Initially approved for AML patients aged 60 and above who have experienced their first relapse and are not suitable for cytotoxic chemotherapy

(3) Approval type: Approved through accelerated approval channels based on response rate data

2. Delisting and relisting

(1) Withdrawal decision: voluntarily withdrawn from the market in 2010 due to lack of survival benefits in confirmatory trials and safety issues

(2) Re study: Conduct new clinical trials after adjusting the dosing regimen (reducing dosage+divided administration)

(3) Re approved: In September 2017, the FDA re approved a new protocol for the diagnosis of CD33 positive AML in adult patients

3. Listing situation in China

(1) Current status: No official approval information from the National Medical Products Administration has been found yet

(2) Usage: Domestic patients can apply for import use through compliant channels

(3) Clinical progress: Relevant clinical trials in China are still ongoing