Lynparza combination therapy gets FDA priority review for prostate cancer
pharmafile | August 17, 2022 | News story | Research and Development |
Lynparza is being jointly developed by UK-based AstraZeneca and MSD
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).
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 patients with mCRPC may receive only one line of active treatment, with 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 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, said: “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.
“[This] 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.”
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.
John Pinching
