Products
Gemtuzumab ozogamicin is approved as a powder for a concentrate for the preparation of an infusion solution (Mylotarg). It was approved in the United States in 2017, in the EU in 2018, and in many countries in 2019 It was previously marketed in the United States between 2000 and 2010 but was withdrawn from the market in the interim due to safety and efficacy concerns. Re-registration became possible due to new studies. In 2017, inotuzumab ozogamicin was also approved (Besponsa).
Structure and properties
Gemtuzumab ozogamicin is an antibody-drug conjugate directed against CD33. Gemtuzumab is a humanized lgG4 monoclonal antibody that binds to CD33. Through a linker, the antibody is linked to calicheamicin (-acetyl-gamma-calicheamicin), which has cytotoxic properties.
Effects
Gemtuzumab ozogamicin (ATC L01XC05) has cytotoxic properties. It binds to and is taken up by CD33-expressing tumor cells. Inside the cell, calicheamicin is released by hydrolytic cleavage of the linker. It causes double-strand breaks in DNA, which arrests the cell cycle and induces cell death by apoptosis. CD33 is a glycoprotein expressed on the surface of cancer cells.
Indications
For the treatment of CD33-positive acute myeloid leukemia (ALL).
Dosage
According to the SmPC. The drug is administered as an intravenous infusion.
Contraindications
- Hypersensitivity
For complete precautions, see the drug label.
Adverse effects
The most common potential adverse effects include bleeding and infectious disease.