FDA Grants Priority Review to Lynparza/Abiraterone for Metastatic Prostate Cancer


The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2022.

The FDA has accepted and granted priority review of a supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC). The FDA has set a Prescription Drug User Fee Act (PDUFA) date in the fourth quarter of 2022.

Lynparza is a first-in-class PARP inhibitor developed by Merck and AstraZeneca. It is the first targeted treatment to potentially exploit DNA damage response pathway deficiencies, such as BRCA mutations.

Susan Galbraith, Ph.D., Mb BChir

Susan Galbraith, Ph.D., Mb BChir

“There remains a critical unmet need among patients diagnosed with mCRPC, where the prognosis remains poor, and treatment options are limited,” Susan Galbraith, Ph.D., Mb BChir, executive vice president, oncology R&D, AstraZeneca, said in a press release.

The application is based on the phase 3 PROpel trial, which were presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and later published in NEJMEvidence.

In PROpel, the Lynparza combination reduced the risk of disease progression or death by 34% compared with placebo plus abiraterone and prednisone or prednisolone. Median radiographic progression-free survival (rPFS) was 24.8 months for the Lynparza arm versus 16.6 months for the placebo arm.

About 14% of patients who received the combination treatment discontinued treatment due to an adverse event. The most common adverse events were anemia, fatigue and nausea.

Lynparza is approved in the United States for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA-mutated and certain other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone. Other indications include advanced ovarian cancer, HER2-negative early and metastatic breast cancer, and metastatic pancreatic cancer.

Last month, Merck and AstraZeneca stopped a trial of Lynparza with or without Genentech’s Avastin (bevacizumab) for the treatment of patients with metastatic colorectal cancer. Lynparza as a monotherapy and in combination with Avastin did not meet its objectives at a planned interim analysis. An independent data monitoring committee made the recommendation to discontinue both arms of the study. No new safety issues were seen, and the safety profile was similar to previous studies.

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