Lynparza secures accelerated FDA review for metastatic castration-resistant prostate cancer

pharmafile | January 20, 2020 | News story | Sales and Marketing Cancer, FDA, lynparza, pharma 

Following the recommendation of the tablet formulation of the drug for use on the NHS in England and Wales, news has broken that AstraZeneca and MSD’s Lynparza (olaparib) has been accepted by the FDA in the US under Priority Review

The therapy is indicated in metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations in patients who have progressed following prior treatment with a new hormonal agent.

The drug secured the accelerated review thanks to Phase 3 data demonstrating a 66% reduction in the risk of disease progression or death by 66% compared to Johnson & Johnson’s Zytiga (abiraterone) or Medivation’s Xtandi (enzalutamide) in BRCA1/2 or ATM-mutated mCRPC, meeting the primary endpoint of the study.

Additionally, in the overall population of HRR-mutated mCRPC patients, Lynparza was shown to reduce the risk of disease progression or death by 51% compared to Zytiga or Xtandi, meeting a key secondary endpoint.  

These data were presented at the European Society of Medical Oncology congress last year.

Matt Fellows

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