Af­ter sell­ing Rubra­ca, Clo­vis On­col­o­gy un­veils CRL for po­ten­tial la­bel ex­pan­sion

Clo­vis On­col­o­gy is fac­ing yet an­oth­er set­back with the FDA giv­ing the bat­tled com­pa­ny a com­plete re­sponse let­ter and re­ject­ing a po­ten­tial la­bel ex­pan­sion for its PARP in­hibitor Rubra­ca.

A new SEC fil­ing Fri­day de­tailed how it re­ceived the CRL from the FDA on May 26, re­ject­ing an sN­DA for Rubra­ca as a first-line main­te­nance treat­ment for women with ad­vanced ovar­i­an can­cer who are in com­plete or par­tial re­sponse to a first-line, plat­inum-based chemother­a­py.

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