Pfizer Inc.'s acute myeloid leukemia (AML) drug Mylotarg (gemtuzumab ozogamicin) is heading back to the US market after being withdrawn in 2010, and FDA's re-approval comes with a bonus pediatric indication that was not discussed at a July advisory committee meeting.
FDA approved Mylotarg Sept. 1 for the treatment of adults with newly diagnosed AML whose tumors express the CD33 antigen, an indication for which the Oncologic Drugs Advisory Committee (ODAC) said the drug demonstrated a favorable risk/benefit profile
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?