AstraZeneca PLC (LSE:AZN) has suffered a setback in its bid to deploy a key drug broadly in prostate cancer, with an influential US panel calling for a limit on its use.
The Oncologic Drugs Advisory Committee (ODAC) told the Food and Drug Administration (FDA) that Lynparza, when combined with other drugs, showed a favourable benefit-risk profile for certain patients with advanced prostate cancer.
However, it voted to curb its use to patients whose tumours have a specific mutation called BRCA.
“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 [the] ODAC meeting,” said AZ’s head of oncology R&D, Susan Galbraith.
“We strongly believe in the results of the PROpel trial, which demonstrated the clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status."
Lynparza was jointly developed with fellow drug developer MSD.
AZ shares were little changed in early trade at £117.86.