With the walls closing in for Clovis, FDA demands ovarian cancer restriction for Rubraca

The U.S. regulator is asking Clovis to limit Rubraca’s use for the second-line maintenance treatment of ovarian cancer to patients whose tumors have BRCA mutations, the company said Wednesday, citing a Monday teleconference with the FDA. The drug’s current label allows it to treat patients with recurrent ovarian cancer who’ve responded to chemo regardless of their BRCA biomarker status.