Pfiz­er’s da­ta min­ing hits pay dirt as FDA pan­el backs a come­back for My­lotarg

Sev­en years ago, My­lotarg was an em­bar­rass­ment for Pfiz­er and the FDA. Reg­u­la­tors forced it off the mar­ket in 2010, right af­ter Pfiz­er’s big Wyeth buy­out and 10 years af­ter it was giv­en the agency’s first ac­cel­er­at­ed ap­proval. The drug failed a con­fir­ma­to­ry study years af­ter it hit the mar­ket, and the FDA yanked it.

To­day, though, the drug made a big step back to­ward the mar­ket. An FDA ad­vi­so­ry com­mit­tee vot­ed 6 to 1 to en­dorse the drug when added to chemother­a­py for pa­tients with new­ly-di­ag­nosed CD33-pos­i­tive acute myeloid leukemia.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER