Talk:Gemtuzumab ozogamicin
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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)
- Done! Andrew73 15:55, 20 October 2005 (UTC)
Resubmission in 2017
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)
- 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)
Outside USA
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 Was it withdrawn from all markets at the same time in 2010 ?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)
What results on overall survival
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)