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Lynparza in combination with abiraterone granted priority review in US

A new therapy is aimed at patients with metastatic castration-resistant prostate cancer.

AstraZeneca’s supplemental new drug application for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone, has been granted priority review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

Lynparza is being jointly developed and commercialised by UK-based AstraZeneca and MSD – known as Merck & Co in the US and Canada. The Food and Drug Administration (FDA) grants priority review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

In the US, prostate cancer is the second most common cancer in male patients and is projected to cause approximately 35,000 deaths in 2022. Overall survival for patients with mCRPC is approximately three years in clinical trial settings and even shorter in the real world. Approximately half of the patients with mCRPC may receive only one line of active treatment, with the diminishing benefit of subsequent therapies.

The new drug application was based on results from the PROpel phase 3 trial presented at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium. These results showed that Lynparza in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone.

Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, reflected: “There remains a critical unmet need among patients diagnosed with metastatic castration-resistant prostate cancer, where the prognosis remains poor and treatment options are limited.”

“Today’s news is another step towards bringing forward a new, much-needed treatment option in this setting. If approved, Lynparza with abiraterone will become the first combination of a PARP inhibitor and a new hormonal agent for patients with this disease,” she added.

Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, MSD Research Laboratories, concluded: “MSD is committed to developing new treatment options for patients with metastatic castration-resistant prostate cancer, a complex disease that urgently needs more therapies. We look forward to working with the FDA towards the goal of bringing a new option to patients with mCRPC with or without HRR gene mutations.”