FDA rejects Regeneron’s bispecific for lymphoma over confirmatory trial status

Re­gen­eron has hit a snag in its at­tempt to bring a new bis­pe­cif­ic an­ti­body to the mar­ket, as the FDA re­ject­ed odronex­tam­ab across two types of blood can­cers.

Ac­cord­ing to the com­pa­ny, the “on­ly ap­prov­abil­i­ty is­sue is re­lat­ed to the en­roll­ment sta­tus of the con­fir­ma­to­ry tri­als,” and the agency didn’t iden­ti­fy any prob­lems with ef­fi­ca­cy, safe­ty, tri­al de­sign, la­bel­ing or man­u­fac­tur­ing in the com­plete re­sponse let­ters.

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