FDA Expands Rucaparib Approval to Include Maintenance Treatment of Recurrent Ovarian Cancer

Today, the U.S. Food and Drug Administration (FDA) approved rucaparib (Rubraca) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The FDA granted regular approval for rucaparib in this second, broader, and earlier-line indication on a Priority Review timeline based on positive data from the phase III ARIEL3 clinical trial. In addition to granting rucaparib approval in this second indication, the FDA converted the approval of the initial treatment indication from accelerated to regular approval.

“Rucaparib provided statistically significant improvement in progression-free survival vs placebo to all patients, regardless of BRCA mutation status,” said Robert L. Coleman, MD, Professor and Executive Director, Cancer Network Research; Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center; and a principal investigator in the ARIEL3 clinical trial program. “Both the efficacy and safety results from the ARIEL3 study reinforce the important role of rucaparib in the treatment of recurrent ovarian cancer and expands the treatment options for patients and physicians battling this disease.”

Rucaparib was initially approved in December 2016 as monotherapy for the treatment of patients with deleterious BRCA mutation–associated advanced ovarian cancer who have been treated with two or more chemotherapies. In December 2017, FDA accepted the rucaparib supplemental new drug application and granted Priority Review status. Priority Review designation is granted to proposed medicines that FDA has determined have the potential, if approved, to offer a significant improvement in the safety or effectiveness for the treatment, prevention, or diagnosis of a serious condition when compared to standard applications.

On February 28, 2018, rucaparib was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology Ovarian Cancer as maintenance therapy for patients with platinum-sensitive epithelial ovarian, fallopian tube, and primary peritoneal cancer who are in partial or complete response after completion of two or more lines of platinum-based therapy. The NCCN designated rucaparib as a category 2A treatment.

ARIEL3 Results

The rucaparib maintenance treatment approval is based on positive results from the ARIEL3 study, which evaluated rucaparib in the ovarian cancer maintenance-treatment setting among three populations: (1) BRCA-mutant; (2) homologous recombination deficiency–positive, inclusive of BRCA-mutant diseaseand (3) all patients treated in ARIEL3. The study enrolled a total of 564 patients.

ARIEL3 successfully achieved both its primary and key secondary endpoints, extending investigator assessed progression-free survival vs placebo in all patients treated, regardless of BRCA status.

Clovis announced topline results from the ARIEL3 clinical trial in June 2017. Additional data from the trial were presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference in Madrid, and subsequently published in The Lancet.

The safety evaluation of rucaparib at 600 mg twice daily as monotherapy for maintenance treatment is based on data from 561 patients with recurrent ovarian cancer treated in the ARIEL3 trial. The safety and tolerability of rucaparib observed in this study were consistent with previous studies of the treatment.

The most common adverse reactions (≥ 20% of patients; CTCAE grade 1–4) were nausea, fatigue/asthenia, abdominal pain/distention, rash, dysgeusia, anemia, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation, constipation, vomiting, diarrhea, thrombocytopenia, nasopharyngitis/upper respiratory tract infection, stomatitis, decreased appetite, and neutropenia. The most common laboratory abnormalities (≥ 25% of patients; CTCAE grade 1–4) were increase in creatinine, decrease in hemoglobin, increase in cholesterol, increase in ALT, increase in AST, decrease in platelets, decrease in leukocytes, decrease in neutrophils, increase in alkaline phosphatase, and decrease in lymphocytes.

The majority of adverse reactions and laboratory abnormalities were grade 1 or 2.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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