Prostate cancer tends to spread to the bones, so reducing the size of those particular tumors can have a meaningful impact on patients, according to the trial’s lead investigator, Maha Hussain, M.D., of Northwestern Medicine. 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). “I think that’s where there will be a real learning curve among practicing physicians,” he said. May 15, 2020, That means the approval was granted based on results from a clinical trial that strongly suggests rucaparib could be beneficial for patients—such as an improvement in progression-free survival—although that level of proof is not yet available. And although most patients seem to handle the side effects caused by both drugs relatively well, he continued, they can cause substantial problems, including anemia, severe drops in white blood cell count, nausea, and vomiting.“These drugs definitely require close monitoring [of patients],” Dr. Sartor said. June 11, 2020, “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. The Food and Drug Administration (FDA) hasn’t approved any PSMA-targeted imaging agents, so PSMA PET-CT isn’t available in the United States outside of clinical studies, explained Lalitha Shankar, M.D., Ph.D., of the Cancer Imaging Program in NCI’s Division of Cancer Treatment and Diagnosis. by NCI Staff Cohort A included men with alterations in the All of the men in the trial had cancer that had worsened despite treatment with either The 387 men in the trial were randomly assigned to either the treatment group, which received olaparib, or the In addition, men treated with olaparib were far more likely to see their tumors shrink (a tumor response) than men treated with one of the other two drugs (33% versus 2%). The recommended niraparib dose for first-line maintenance treatment of advanced ovarian cancer is based on body weight or platelet count. Because bone metastases are often hard and dense, she said, biopsies of these sites are “notorious for not having enough tissue to do standard genetic sequencing.”In addition to tissue quantity, there are also issues with the type of tissue that comes from the biopsy and its quality. Credit: Adapted from Genes. As of May 23, among 165 enrolled patients, 81 had biallelic DRD, and a minimum of 16 weeks of follow up, including 29 with Janssen said in a statement that they believe niraparib will be an important treatment for certain prostate cancers. Pre-specified interim analysis of GALAHAD: a phase 2 study of niraparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD). 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. The PARP inhibitor continues to be investigated in patients with metastatic CRPC in the ongoing phase III MAGNITUDE trial (NCT03748641).
by NCI Staff One potential advantage of rucaparib over olaparib could be the eventual availability of a blood test, called a One reason that’s important, Dr. Karzai explained, also comes back to the fact that prostate cancer so often spreads to the bones. Two recent approvals by the Food and Drug Administration (FDA) have opened a new avenue of treatment for some men with prostate cancer: an expanded role for targeted therapies.Many treatments of metastatic prostate cancer are centered around therapies that block the ability of Studies have shown that 20%–30% of men with metastatic prostate cancer have genetic alterations that impair cells’ DNA repair mechanisms. June 12, 2020, FDA has approved olaparib (Lynparza) and rucaparib (Rubraca) to treat some men with metastatic prostate cancer. 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. 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).
CC BY 4.0 Niraparib is approved by the FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a CR or PR to platinum-based chemotherapy. Among the most frequent such alterations are those in the It’s no accident that researchers have identified people who have alterations in Prostate cancer emerged as another strong candidate for PARP inhibitors after studies suggested that alterations in Those findings, Dr. Karzai explained, led to a series of Olaparib’s approval, announced on May 19, was based on the results of a large clinical trial called PROFOUND.