The US Food and Drug Administration (FDA) has approved Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adults with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
The approval was based on data from the phase 3 PROpel trial (ClinicalTrials.gov Identifier: NCT03732820), which included 796 adults with mCRPC who had not received prior chemotherapy or new hormonal agents in the mCRPC setting. Patients were randomly assigned 1:1 to receive either olaparib at 300 mg orally twice daily or placebo, in addition to abiraterone and prednisone or prednisolone.
The primary endpoint was radiological progression free survival (rPFS). Results showed a statistically significant improvement in rPFS with olaparib compared with placebo in the intent-to-treat population.
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In an exploratory subgroup analysis of 85 patients with a BRCA gene mutation, olaparib demonstrated improvements in rPFS (hazard ratio [HR], 0.24; 95% CI, 0.12-0.45) and overall survival (HR, 0.30; 95% CI, 0.15-0.59) compared with placebo.
The median rPFS was not reached in the olaparib arm and was 8 months in the placebo arm. The median overall survival was not reached in the olaparib arm and was 23 months in the placebo arm.
As for safety, the most common adverse reactions reported with olaparib in combination with abiraterone and prednisone or prednisolone were anemia (48%), fatigue (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia and dizziness (14% each), and abdominal pain (13%).
Lynparza, a PARP inhibitor, is also approved for the treatment of adults with deleterious or suspected deleterious germline or somatic HRR gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone.
Additionally, Lynparza is indicated for the treatment of ovarian cancer, breast cancer, and pancreatic cancer.
References
FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer. News release. US Food and Drug Administration. May 31, 2023. Accessed June 1, 2023.
Lynparza plus abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer. News release. AstraZeneca and Merck. Accessed June 1, 2023.
FDA approves Lynparza® (olaparib) plus abiraterone and prednisone or prednisolone for treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). News release. AstraZeneca and Merck. Accessed June 1, 2023.
Lynparza. Package insert. AstraZeneca; 2023. Accessed June 1, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s025lbl.pdf.
This article originally appeared on MPR
