Tib­so­vo clears an­oth­er hur­dle for Servi­er, but can it make Agios' old drug prof­itable?

When Eu­ro­pean reg­u­la­tors saw the da­ta Agios used to win US ap­proval for their AML drug Tib­so­vo, they sent the more than decade-old biotech back to the draw­ing board. A sin­gle, sin­gle-armed tri­al was not go­ing to cut it.

On Mon­day, though, the drug’s new own­ers an­nounced it had cleared a more rig­or­ous study. In a ran­dom­ized, Phase III tri­al of cer­tain new­ly di­ag­nosed pa­tients, those who re­ceived a com­bi­na­tion of Tib­so­vo and chemother­a­py lived longer than those who re­ceived a com­bi­na­tion of place­bo and chemother­a­py. Those pa­tients al­so had high­er re­sponse rates and com­plete re­mis­sion rates.

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