June 19 (Reuters) - Clovis Oncology Inc said its ovarian cancer drug Rubraca slowed disease progression in a late-stage trial involving patients with various gene mutations who had undergone initial therapy.
The U.S. Food and Drug Administration last December granted Rubraca accelerated approval in patients whose tumors have a mutation called BRCA, and whose disease had advanced despite two or more rounds of chemotherapy.
Based on the findings of the trial announced on Monday, Clovis plans to submit an application within the next four months to expand Rubraca’s label.
Rubraca, like Tesaro Inc’s niraparib and AstraZeneca Plc’s lynparza, belongs to a closely watched class of new medicines called PARP inhibitors, which block enzymes involved in repairing damaged DNA, thereby helping to kill cancer cells. (Reporting by Natalie Grover in Bengaluru; Editing by Amrutha Gayathri)