Gemtuzumab is a monoclonal antibody that interferes with the synthesis of Deoxyribonucleic Acid (DNA) in cancer cells. The medication was originally introduced for the treatment of acute myeloid leukemia. As is common with new medications, the manufacturer additional research to determine if it had useful properties for the management of other conditions. In the United States, it was later withdrawn from the open market. Some regions of the world only make it available for clinical trials investigating the applications of the medication.
Original studies on gemtuzumab suggested it could be effective in cases of relapsed leukemia in older patients. People over the age of 60 who couldn’t take other chemotherapy medications and had recurrent cancers could potentially be good candidates for gemtuzumab therapy. Careful monitoring throughout therapy was necessary to identify side effects as quickly as possible. This included checkups and blood tests to assess response to the medication.
The drug is not recommended for use in combination chemotherapy. Patients who take it may need to avoid some other medications to reduce the risk of serious drug interactions. As with many chemotherapy drugs, it can cause side effects like nausea, fatigue, and dizziness. Some patients experience acute allergic reactions or liver problems while on the drug. For this reason, it may be necessary to take some tests before starting therapy to confirm that the drug is a good choice.
In the United States, gemtuzumab was taken through the accelerated approval process to make it accessible to patients as quickly as possible in 2000. The medication was used for approximately 10 years before research indicated that it did not offer enough benefits to patients to merit the risks. Observers noted an increased risk of patient death on gemtuzumab therapy, with outcomes comparable to other medications that were safer to use. The manufacturer voluntarily withdrew the drug from the open market in response to these findings.
Other nations hadn’t yet approved gemtuzumab and held it in clinical trials. In these regions, the medication is only available to patients who enroll in trials and meet the standards set by trial designers. This usually means that they have specific cancers with a particular medical history. Researchers try to avoid patients with multiple conditions and complications, because it can be hard to generalize data from their treatment to other people with cancer. People eligible for clinical trial participation can discuss appropriate options with their doctors.
