PARP Inhibitors’ Data on Later Line Use in Ovarian Cancer Prompts Indication Withdrawals

Since June, manufacturers of the three FDA-approved poly (ADP-ribose) polymerase (PARP) inhibitors have withdrawn their indications in the later line treatment setting for ovarian cancer. Payers should be reviewing their utilization management criteria to make sure they are covering the drugs in the appropriate setting, advises one industry expert.

In a Form 8-K filed with the U.S. Securities and Exchange Commission on June 16, Clovis Oncology, Inc. said it was voluntarily withdrawing the FDA approval for Rubraca (rucaparib) for the treatment of BRCA-mutated ovarian cancer after at least two chemotherapies based on overall survival (OS) data from the ARIEL4 clinical trial. The company also disclosed that it had requested withdrawal of that indication in Europe. The drug’s indications for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and for the treatment of adults with a deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy, the latter of which has accelerated approval, remain on its label.