FDA Approval: Gemtuzumab ozogamicin for the treatment of adults with newly-diagnosed CD33-positive acute myeloid leukemia

On September 1, 2017, FDA granted approval for gemtuzumab ozogamicin (GO) (Mylotarg; Pfizer, Inc) in combination with daunorubicin and cytarabine (DA) and as a monotherapy for the treatment of adult patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML). GO is a CD33-targeted antibody-drug conjugate joined to calicheamicin. Approval of GO combination treatment was based on a randomized trial of 271 patients with newly-diagnosed AML treated with DA with or without 3 mg/m2 fractionated GO, which resulted in an event-free survival (EFS) of 13.6 months for GO + DA and 8.8 months for DA alone (HR 0.68 [95% CI: 0.51-0.91]). Hemorrhage, prolonged thrombocytopenia, and veno-occlusive disease were serious toxicities that were more common in patients treated with GO + DA. Approval of GO monotherapy was based on a randomized trial of 237 patients with newly-diagnosed AML treated without curative intent. Median overall survival (OS) was 4.9 months with GO versus 3.6 months on best supportive care (HR 0.69, [95% CI 0.53-0.90]). Adverse events were similar on both arms. Post-approval, several studies are required including evaluation of fractionated GO pharmacokinetics, safety of combination GO in the pediatric population, of immunogenicity, and of the effects of GO on platelet function.

from Cancer via ola Kala on Inoreader http://ift.tt/2sSseEJ
via IFTTT