Zejula a New Maintenance Treatment Option for Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Web Exclusives - FDA Approvals

On March 27, 2017, the FDA accelerated the approval of niraparib (Zejula; Tesaro), a PARP inhibitor, for maintenance treatment of 3 types of cancers—recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer—in adults who had a complete or partial response to platinum-based chemotherapy.

“Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment,” said Richard Pazdur, MD, Acting Director of the FDA’s Center for Drug Evaluation and Research and Director of the FDA’s Oncology Center of Excellence. “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation,” he added.

The FDA approval was based on a randomized clinical trial of 553 patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, who had received ≥2 platinum-based chemotherapies and had a complete or a partial response to the most recent chemotherapy regimen.

All patients were tested for BRCA mutation with the FDA-approved BRACAnalysis CDx test. The median progression-free survival (PFS) was 21 months in patients with a BRCA mutation who received niraparib versus 5.5 months in patients who received placebo. Among patients without a BRCA mutation, the median PFS was 9.3 months with niraparib versus 3.9 months with placebo.

The most common (≥10%) all-grade adverse events with niraparib were thrombocytopenia, anemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain or distention, mucositis or stomatitis, diarrhea, dyspepsia, dry mouth, fatigue/asthenia, decreased appetite, urinary tract infection, elevations in AST or ALT levels, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypertension.

The most common grade 3 or 4 adverse reactions included neutropenia, nausea, constipation, diarrhea, urinary tract infection, elevations in AST or ALT levels, dyspnea, and hypertension.

Niraparib received a breakthrough therapy designation for these 3 types of cancer, and an orphan drug designation for recurrent epithelial ovarian cancer.

Related Items
FDA Grants Approval to Avapritinib for Patients with GIST
Yvette Florio Lane
Web Exclusives published on January 14, 2020 in FDA Approvals, In the News
Recap of FDA Drug Approvals in 2019
Yvette Florio Lane
Web Exclusives published on January 8, 2020 in FDA Approvals, In the News
Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma
Yvette Florio Lane
Web Exclusives published on December 11, 2019 in FDA Approvals, In the News
FDA Oncology Update
November 2019 Vol 12, No 7 published on December 5, 2019 in FDA Approvals
November 11, 2019 — Oncology News & Updates
Web Exclusives published on November 13, 2019 in Drug Updates, FDA Approvals, In the News
Last modified: May 22, 2017
  •  Association for Value-Based Cancer Care
  • Oncology Practice Management
  • Value-Based Cancer Care
  • Value-Based Care in Rheumatology
  • Rheumatology Practice Management
  • Urology Practice Management
  • Lynx CME