Overall survival (OS) was an additional endpoint.Ī statistically significant improvement in rPFS for olaparib with abiraterone compared to placebo with abiraterone in the intent-to-treat (ITT) population was observed. The major efficacy outcome measure was investigator-assessed radiological progression-free survival (rPFS) per RECIST version 1.1 for soft tissue and Prostate Cancer Working Group criteria for bone lesions. All available clinical samples were retrospectively tested for BRCA mutational status with the FoundationOne CDx and FoundationOne Liquid CDx tests (Foundation Medicine, Inc.). Randomization was stratified by site of metastases and prior docetaxel. Patients with prior systemic therapy for mCRPC were excluded however, prior docetaxel for metastatic hormone-sensitive prostate cancer was allowed. Patients were required to have a prior orchiectomy and, if not performed, received gonadotropin-releasing hormone (GnRH) analogs. View full prescribing information for Lynparza.Įfficacy was evaluated in the PROpel trial (NCT03732820) that enrolled 796 patients with mCRPC, Patients were randomized (1:1) to receive either olaparib with abiraterone or placebo with abiraterone and also received prednisone or prednisolone. On May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated ( BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.
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