FDA Panel Votes Against Broad Talazoparib-Enzalutamide Label in Prostate Cancer
An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib (Talzenna) plus enzalutamide (Xtandi) for all patients with metastatic castration-resistant prostate cancer (mCRPC). In an 8-0 vote, members of the Oncologic Drugs Advisory Committee (ODAC) said the available data from the TALAPRO-2 trial do not support a favorable risk-benefit […]
Multi-Agent Treatment Offers Hope in Advanced or Recurrent Endometrial Cancer
MADRID — Immunotherapy, chemotherapy, and a PARP inhibitor in the first line improved progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer, according to the DUO-E trial. The trial assessed the combination of durvalumab (Imfinzi) and platinum-based chemotherapy, followed by maintenance therapy with either durvalumab plus the PARP inhibitor olaparib (Lynparza) or durvalumab […]
FDA Approves Fixed-Dose Prostate Cancer Combination Treatment
The FDA approved the first fixed-dose combination of the PARP inhibitor niraparib and the androgen biosynthesis inhibitor abiraterone (Akeega) for metastatic BRCA-mutant castration-resistant prostate cancer (CRPC). The approval stipulates use of the dual-action tablet with prednisone in patients with metastatic BRCA-mutant CRPC confirmed by an FDA-approved diagnostic test. Eligible patients must have had prior bilateral […]
FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancer
The FDA has approved the PARP inhibitor olaparib (Lynparza) in combination with abiraterone (Zytiga) for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), the agency announced Wednesday. Adult patients should be selected for the combination therapy — which is given with prednisone (or prednisolone) — based on an FDA-approved companion diagnostic test to detect deleterious or suspected […]
Add-On Olaparib Continues to Show Benefit in First-Line Treatment of mCRPC
SAN FRANCISCO — Adding the PARP inhibitor olaparib (Lynparza) to standard-of-care abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (mCRPC) extended median progression-free survival (PFS), according to final results of the double-blind phase III PROpel study reported here. There was also a trend toward an improvement in median overall survival (OS). At the […]
Adding Talazoparib to Enzalutamide Boosts PFS in Metastatic Prostate Cancer
SAN FRANCISCO — Treatment with the PARP inhibitor talazoparib (Talzenna) plus enzalutamide (Xtandi) significantly improved radiographic progression-free survival (rPFS) compared with enzalutamide plus placebo in patients with metastatic castration-resistant prostate cancer (mCRPC), the phase III TALAPRO-2 trial showed. Among 805 randomized patients, rPFS assessed by blinded independent central review was not reached in those who […]
Rucaparib Gets a Win in Metastatic Castration-Resistant Prostate Cancer
SAN FRANCISCO — Imaging-based progression-free survival (PFS) was significantly longer with the PARP inhibitor rucaparib (Rubraca) compared with physician’s choice of therapy in patients with BRCA or ATM-associated metastatic castration-resistant prostate cancer (CRPC), the phase III TRITON3 study showed. All patients in the study had already progressed after treatment with a second-generation androgen receptor-pathway inhibitor […]
Chemo-Free Maintenance Combo Promising in Pancreatic Cancer
Pairing a PARP inhibitor and immune checkpoint inhibitor together may be a viable non-cytotoxic maintenance therapy option for patients with platinum-sensitive pancreatic ductal adenocarcinoma (PDAC), according to findings of a single-center phase Ib/II study. At a median follow-up of 23.0 months, combining the PARP inhibitor niraparib (Zejula) with the anti CTLA-4 antibody ipilimumab (Yervoy) achieved […]
Two PARP Inhibitors Impress as First-Line Add-Ons in mCRPC
Adding PARP inhibition to first-line abiraterone (Zytiga) reduced the risk of radiographic progression or death in metastatic castration-resistant prostate cancer (mCRPC), a pair of phase III studies showed. In PROpel, patients who received olaparib (Lynparza) along with abiraterone plus prednisone had a roughly 8-month improvement in median radiographic progression-free survival (rPFS) versus those assigned placebo […]