Talk:Gemtuzumab ozogamicin

Latest comment: 6 years ago by Rod57 in topic Resubmission in 2017

Thank you, Andrew, for writing up mylotarg. Perhaps some references, especially on the role in causing VOD, would improve the article. JFW | T@lk 13:25, 20 October 2005 (UTC)Reply

Done! Andrew73 15:55, 20 October 2005 (UTC)Reply

Resubmission in 2017 edit

With results from the ALFA-0701 CT Pfizer are resubmitting (for marketing approval) to US FDA and EU.Feb 2017. Possibly for slightly different indication ? - Rod57 (talk) 14:17, 5 February 2017 (UTC)Reply

Sept 2017 says "The new FDA approval is for a lower recommended dosage range and a different administration schedule than the previous approval, and includes uses alone or in combination with chemotherapy. Additionally, the new FDA approval is for a different patient population than before, including adults with newly diagnosed CD33-positive AML, as well as certain younger patients who had experienced a relapse or had not responded to initial treatment. " - Rod57 (talk) 16:18, 20 September 2017 (UTC)Reply

Outside USA edit

Was it ever approved by the EU ? When was it approved by Japan ? any others ? Was it withdrawn from all markets at the same time in 2010 ? - Rod57 (talk) 14:29, 5 February 2017 (UTC)Reply

What results on overall survival edit

Has any study reported on or even estimated overall survival with GO ? Perhaps the trial that was stopped early was designed to do this ? - Rod57 (talk) 14:43, 5 February 2017 (UTC)Reply