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.
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Stockwatch: Can Gilead Wave Its Wand Over Antibody-Drug Conjugates?
After a slow start marked by product withdrawals and toxicity, recent deal-making activity has brought antibody-drug conjugates back from obscurity. But what has changed?
Mylotarg, Event-Free Survival Endpoint Both Get FDA Panel Endorsement
Oncologic Drugs Advisory Committee votes 6-1 that benefits of Pfizer's Mylotarg outweigh risks, positioning drug for return to market after being withdrawn in 2010; vote could also open door for future acute myeloid leukemia products to use event-free survival as endpoint.
A CASCADE Of Trouble For Seattle Genetics' AML Drug SGN-CD33A
Seattle Genetics will discontinue all trials of vadastuximab talrine, including the Phase III CASCADE trial in frontline older acute myeloid leukemia patients after a higher rate of deaths was seen.