Clovis’s Rubraca Is First PARP For Prostate Cancer, But AZ’s Lynparza Coming Soon
The limitations of launching during the pandemic will make it difficult to capitalize on a short window between the approvals.
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With a PDUFA date fast approaching, AstraZeneca has presented more data from the PROfound study, this time showing that Lynparza improved OS compared to hormonal therapies in men with advanced castration-resistant prostate cancer with BRCA1/2 or ATM mutations.
The detailed data from PROfound showed the PARP inhibitor doubled the time to radiographic progression-free survival in men with homologous recombination repair (HRRm) gene mutations.
The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.