Mylotarg Pulled Off Market, But Pfizer Continues Search For Appropriate Population
This article was originally published in The Pink Sheet Daily
Executive Summary
After a futile confirmatory trial, Pfizer will review ongoing studies to see if they can be refined to indentify patients that could benefit from the drug, oncology VP Eagle says.
You may also be interested in...
Pfizer's Mylotarg Rejoins AML Market At $24,600 List Price
CD33 inhibiting drug that was yanked from the market in 2010 due to reports of veno-occlusive disease is now fully approved by the US FDA at a lower recommended dose.
After Inotuzumab: New Platforms Promise More Than Better Antibody-Drug Conjugates
Versatile next-generation antibody-drug conjugate platforms promise to turn out ADCs with better specificity and safety than current technologies, as well as combination therapeutics like bi-specific antibodies, but old-school molecules continue to move through clinical trials and gain approval.
Eisai Will Make “Totality Of The Evidence” Argument At FDA Panel Review Of Dacogen
Briefing documents for the Oncologic Drugs Advisory Committee’s Feb. 9 meeting suggest Eisai will argue that the totality of the data on decitabine’s efficacy and safety in elderly patients with acute myelogenous leukemia is sufficient to overcome the pivotal trial’s failure to show a statistically significant overall survival benefit in the primary analysis. In contrast, FDA’s review takes a laser-like focus on the failed primary endpoint.