Lynparza Receives FDA Approval With Abiraterone for Treatment of Specific Patients With Prostate Cancer

The Food and Drug Administration (FDA) approved Lynparza (olaparib) for use with abiraterone and prednisone to treat adults with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, the FDA announced on Wednesday.

This approval was based on findings from the PROpel trial, which demonstrated that Lynparza plus abiraterone significantly improved radiological progression-free survival (the time during and after treatment when a patient with cancer lives without disease worsening) compared with placebo with abiraterone, according to a press release from the FDA. In particular, progression-free survival was not reached in patients with metastatic castration-resistant prostate cancer assigned Lynparza plus abiraterone — meaning that more than half of patients in the trial did not meet this outcome — compared with eight months in patients assigned placebo with abiraterone.

Findings from the PROpel trial also showed that the improvement in radiological progression-free survival was primarily a result of patients with metastatic BRCA-mutated metastatic castration-resistant prostate cancer, according to the release.

The most common side effects in the trial, which occurred in at least 10% of patients treated with Lynparza plus abiraterone, included fatigue (38%), anemia (48%), diarrhea (19%), nausea (30%), lymphopenia (14%), decreased appetite (16%), abdominal pain (13%) and dizziness (14%). In addition, 72 patients from the trial —18% of the population — needed at least one blood transfusion, and 46 patients (12%) required several transfusions, according to the release.

In the PROpel trial, researchers analyzed data from 796 patients with metastatic castration-resistant prostate cancer, according to the listing on ClinicalTrials.gov.

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