FDA approves rucaparib, olaparib for mutated metastatic CRPC
medwireNews: The US FDA has approved two PARP inhibitors for the treatment of metastatic castration-resistant prostate cancer (CRPC) with a deleterious BRCA or homologous recombination repair (HRR) gene mutation.
Rucaparib has been granted accelerated approval for use in men with a germline and/or somatic BRCA mutation who have previously received androgen receptor inhibitor therapy and taxane-based chemotherapy.
The decision is based on the TRITON2 trial findings and the treatment is recommended at the study dose of 600 mg twice daily alongside gonadotrophin-releasing hormone therapy or bilateral orchiectomy.
The FDA has also approved the use of olaparib for metastatic CRPC patients with deleterious or suspected deleterious germline or somatic mutation to an HRR gene, and who have already experienced disease progression while using enzalutamide or abiraterone.
The approval follows the PROfound trial results, which demonstrated significant survival benefits for patients with BRCA1, BRCA2, or ATM mutations compared with an investigator’s choice of enzalutamide or abiraterone, as well as for those with mutations to one of 12 HRR pathway genes.
The recommended olaparib dose is 300 mg twice daily, given concurrently with gonadotrophin-releasing hormone therapy or bilateral orchiectomy.
A companion diagnostic test was also approved for selection of patients for olaparib therapy.
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