Shares in Clovis Oncology were given a nudge by news that US regulators assigned its investigational advanced ovarian cancer treatment with ‘Breakthrough Therapy’ status, potentially accelerating its development timeline.
The US Food and Drug Administration’s designation relates to the use of 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 tumours, inclusive of both germline BRCA and somatic BRCA mutations.
The decision came on the back of interim efficacy and safety results from two ongoing Phase II studies of the drug - an oral, potent inhibitor of PARP1 and PARP2 - indicating significant response rates in patients tested.
Patrick Mahaffy, Clovis’ chief executive, said rucaparib “is the only PARP inhibitor to have shown activity in this broader, but still selected, patient population,” while study investigator Robert Coleman, from the Department of Gynecologic Oncology and Reproductive Medicine at University of Texas Anderson Cancer Center, said “continuing successful development of this drug and its companion diagnostic will be a huge advance for women with this disease”.
Clovis’ stock had risen more than 5% in after-hours trading on Monday.