BRIEF—Mixed FDA AdCom results for Lynparza

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of Lynparza (olaparib) plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

Lynparza is marketing by pharma majors AstraZeneca of the UK and the USA’s Merck & Co.

However, the AdCom voted that the FDA should restrict use of Lynparza plus abi/pred to these BRCAm mCRPC patients, recommending against approval beyond this patient population.

“While we are pleased with the recognition of the benefit of Lynparza plus abiraterone for patients with BRCA-mutated metastatic castration-resistant prostate cancer, we are disappointed with the outcome of today’s ODAC meeting. We strongly believe in the results of the PROpel trial, which demonstrated a clinically-meaningful benefit for this combination in a broad population of patients regardless of biomarker status,” commented Susan Galbraith, executive vice president, oncology R&D at AstraZeneca.

Just before the AdCom meeting, FDA staff issued briefing documents to guide the committee experts, that were seen as somewhat negative.