FDA stiff-arms Aveo on ti­vo, again; Sunovion Parkin­son's drug re­ject­ed

Aveo On­col­o­gy was hit with a fresh set­back on Thurs­day. Its 2013-re­ject­ed tivozanib is still not ready for a new mar­ket­ing ap­pli­ca­tion, the com­pa­ny said, cit­ing FDA feed­back. The agency rec­om­mend­ed that the drug de­vel­op­er not sub­mit the ap­pli­ca­tion as pre­lim­i­nary over­all sur­vival da­ta — re­port­ed last No­vem­ber — did not al­lay their con­cerns about the drug’s use in re­nal cell car­ci­no­ma out­lined in their re­jec­tion let­ter in 2013. The new ap­pli­ca­tion will be made once ma­ture OS re­sults are avail­able. “We are hope­ful that the pos­i­tive PFS (pro­gres­sion-free sur­vival) out­come will trans­late in­to an im­proved haz­ard ra­tio when we eval­u­ate a more ma­ture in­ter­im OS out­come in the fourth quar­ter of 2019,” said Aveo chief Michael Bai­ley said in a state­ment. The com­pa­ny’s shares $AVEO cratered more than 55% in ear­ly trad­ing.

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