Updated
October 6th, 2019

Prostate Cancer Medication Granted FDA Breakthrough Status

Janssen Niraparib is for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer

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The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor.

Janssen Pharmaceutical’s Niraparib is for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy.

Niraparib is a therapeutic medication, not a preventive vaccine.

Metastatic castration-resistant prostate cancer is a form of prostate cancer that has spread to other parts of the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels.

BRCA1/2 mutations are the most common DNA-repair gene defects (DRD) in patients with mCRPC.2 Patients with a DRD in BRCA1/2 are at an elevated risk for both prostate cancer occurrence and more aggressive disease.

More than 1 million people around the world are diagnosed with prostate cancer each year.

“Niraparib is a PARP inhibitor that we believe may help address an important unmet need for patients with metastatic castration-resistant prostate cancer who have mutations in DNA-repair genes,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC, in a October 3, 2019, press release.

The Breakthrough Therapy Designation is based on data from the GALAHAD study, a Phase 2, multicenter, open-label clinical trial evaluating the efficacy and safety of Niraparib in the treatment of adult patients with mCRPC and DRD who had received treatment with next-generation androgen-receptor targeting therapies and docetaxel.

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Data from the Phase 2 GALAHAD study were recently presented at the European Society for Medical Oncology 2019 Annual Congress as a late-breaking abstract.

Ongoing studies for Niraparib include the Phase 3 MAGNITUDE study evaluating Niraparib in combination with ZYTIGA® (abiraterone acetate) and prednisone in adults with metastatic prostate cancer. 

The MAGNITUDE study is evaluating Niraparib plus ZYTIGA® and prednisone in a broader population than GALAHAD in patients with frontline mCRPC disease. 

In addition, QUEST, a Phase 1b/2 study of Niraparib combination therapies for the treatment of mCRPC, is ongoing.

Niraparib is currently marketed as ZEJULA® by TESARO, an oncology-focused business within GSK, devoted to providing transformative therapies to people facing cancer. Please refer to the full Prescribing Information available here.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.

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