Breakthrough Therapy designation for Clovis’ rucaparib

The US Food and Drug Administration has granted Breakthrough Therapy designation for US personalized cancer therapy specialist Clovis Oncology’s (Nasdaq: CLVS) investigational agent rucaparib as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations. The news pushed Clovis’ shares up 5.4% to $72.35 in after-hours trading on Monday.

Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 being developed for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, commonly referred to as “BRCA-like” or “BRCAness.” The Breakthrough Therapy designation was granted based on interim efficacy and safety results from two ongoing Phase II studies of rucaparib in ovarian cancer, including a Phase II trial in women with gBRCA mutations, and the ARIEL2 treatment study.

Peak sales of $1 billion forecast