AstraZeneca and MSD’s – known as Merck & Co in the US and Canada – Lynparza (olaparib) has been approved in the UK as part of a combination therapy for certain prostate cancer patients.
Specifically, the PARP inhibitor is now authorised in combination with anti-androgen therapy Zytiga (abiraterone) and prednisone or prednisolone for adult patients with metastatic castration-resistant prostate cancer (mCRPC) for whom chemotherapy is not clinically indicated.
Prostate cancer is the fifth leading cause of cancer deaths globally. In the UK alone, more than 52,000 men are diagnosed with prostate cancer every year, accounting for more than 140 cases per day.
Around 10-20% of patients with advanced prostate cancer will develop castration-resistant prostate cancer within five years, most cases of which are metastatic.
The decision from the Medicines and Healthcare products Regulatory Agency (MHRA) was based on results from the phase 3 PROpel trial, which showed that Lynparza in combination with abiraterone significantly improved radiographic progression-free survival versus abiraterone alone, regardless of biomarker status.
Results also showed that the combination therapy reduced the risk of disease progression or death by 34% versus abiraterone alone.
The key secondary endpoint of overall survival will continue to be assessed, the companies said, as this data was not yet mature at the time of analysis.
Ed Piper, medical and scientific affairs director, AstraZeneca UK, said the company was “delighted” at the approval, adding that the partners will continue to work with the National Institute for Health and Care Excellence (NICE) and NHS England to “secure access as quickly as possible for patients”.
David Long, head of oncology at MSD UK, added: “This approval from the MHRA marks important progress in advancing a new treatment option to address the significant unmet need of patients with mCRPC.”
Lynparza is also approved in the UK as a monotherapy for adult patients with mCRPC and BRCA1/2 mutations who have progressed following prior therapy that included a new hormonal agent.
The European Commission approved the Lynparza/abiraterone combination in December for patients with mCRPC for whom chemotherapy is not clinically indicated, and the drug also holds a number of approvals for a range of indications for ovarian, breast, fallopian tube, peritoneal and pancreatic cancers.