WebMar 1, 2024 · The NDA is supported by data from the MAGNITUDE study (NCT03748641), a Phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of niraparib plus AAP as a first-line treatment in patients with mCRPC, with or without alterations in HRR associated genes. 1 Patients with HRR gene … WebApr 11, 2024 · At the beginning of the study period, due to economic reasons, niraparib was often reserved as a last resort when patients were resistant or intolerable to …
Janssen Submits New Drug Application to the U.S. Food and Drug ...
WebJan 1, 2024 · This study f … The JASPER clinical trial studied a new combination treatment for advanced or metastatic non-small cell lung cancer (NSCLC). ... ≥50% (cohort 1) or 1%-49% (cohort 2) received first-line niraparib (200 mg once daily) plus pembrolizumab (200 mg every 3 weeks). The primary end point was investigator-assessed objective response ... WebJul 7, 2024 · Despite a very small sample size, it is notable that the median progression-free survival in niraparib plus nivolumab was similar to the placebo group of the POLO study (3·8 months), whereas the median progression-free survival of 10·4 months in the niraparib plus ipilimumab group was closer to that shown in the experimental group of the POLO ... hyllden heights hildenborough
Real-worldoutcomesofniraparibtreatmentinpatients …
WebFeb 1, 2024 · Niraparib late-breaking data: · First results from the Phase 3 MAGNITUDE study of niraparib in combination with abiraterone acetate plus prednisone as a first-line therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations (Abstract #12) … WebThe recommended niraparib dose for first-line maintenance treatment of advanced ovarian cancer is based on body weight or platelet count. For patients weighing less than 77 kg … WebApr 12, 2024 · The investigational PARP inhibitor senaparib (JS109/IMP4297) was found to prolong progression-free survival (PFS) in patients with advanced ovarian cancer, meeting the primary end point of the phase 3 FLAMES study (NCT04169997). 1. Senaparib was designed to selectively bind to PARP 1/2 and prevent PARP-mediated repair of single … hyl lc tablet