The FDA has granted a breakthrough therapy designation to niraparib (Zejula) for the treatment of men with The agency based its action on the PARP inhibitor – which is already approved for use in ovarian and other gynecologic cancers – from an interim analysis of the ongoing, multicenter, open-label phase II GALAHAD trial, designed to evaluate the efficacy and safety of niraparib in patients with mCRPC who have Trial results were recently presented at the European Society of Medical Oncology 2019 CongressThe primary endpoint was objective response rate (ORR), while secondary endpoints included median progression-free survival (PFS) and overall survival (OS). The drugs, both PARP inhibitors, are approved to treat men whose cancers have stopped responding to hormone treatments and have specific genetic alterations that affect DNA repair, including BRCA mutations.
For … by NCI Staff “I think that’s where there will be a real learning curve among practicing physicians,” he said.

The QUEST trial is also underway, a phase Ib/II look into niraparib combination therapies.Smith MR, Sandhu S, Kelly WK, et al. Presented at: 2019 ESMO Congress; September 27-October 1, 2019; Barcelona, Spain. PARP inhibitors work in part by blocking the ability of PARP proteins to repair damaged DNA, which includes recruiting other DNA repair proteins (multicolored circles). The FDA has granted a breakthrough therapy designation to niraparib (Zejula) for the treatment of men with BRCA1/2 -mutant positive metastatic castration-resistant prostate cancer (mCRPC) who have previously received taxane-based chemotherapy and an androgen receptor (AR) inhibitor, according to Janssen, the drug’s developer. The trial enrolled men with mutations in DNA repair genes and divided them into two cohorts.
“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, MD, vice president, clinical development, solid tumors, at Janssen Research and Development, LLC. “I think it’s exciting.”Over the past decade, olaparib and rucaparib have become important treatments for women with ovarian and breast cancer, in whom genetic alterations that affect DNA repair processes are common.

FDA Approves Zejula (niraparib) as the Only Once-Daily PARP Inhibitor in First-Line Monotherapy Maintenance Treatment for Women with Platinum-Responsive Advanced Ovarian Cancer Regardless of Biomarker Status: Oct 23, 2019: FDA Approves Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer So, to now have two new approved therapies for these men, and in such rapid succession, “is good news for patients,” said Oliver Sartor, M.D., medical director of the Tulane Cancer Center and a prostate cancer expert.Fatima Karzai, M.D., clinic chief of the Genitourinary Malignancies Branch in NCI’s “In prostate cancer, we’re now starting to see the benefits of these targeted therapies,” she continued. Similar to the PROFOUND trial, TRITON2 enrolled men with alterations in a host of DNA repair genes, the largest group of which was those with According to data presented at the ESMO meeting late last year—and similar to what was seen in PROFOUND—men with Often, when multiple drugs are approved for the same—or in this case, a very similar—use, the side effects associated with each drug can help doctors decide which therapy is best for each patient.Overall, Dr. Sartor explained, there aren’t notable differences in the types or severity of the side effects caused by olaparib and rucaparib.


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