OR WAIT null SECS
The decision was based on results from the PROpel Phase III trial.
AstraZeneca and MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, announced on March 20, 2023 that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lynparza (olaparib) in the United Kingdom for use as combination therapy with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) when chemotherapy is not clinically indicated.
The decision was based on results from the PROpel Phase III trial, which showed that AstraZeneca and MSD’s Lynparza, in combination with abiraterone, significantly improved radiographic progression-free survival (rPFS) versus abiraterone alone as a first-line treatment for patients with mCRPC regardless of their biomarker status.
The results additionally show that combination therapy reduced the risk of disease progression or death by 34% versus abiraterone alone. As for adverse reactions, Lynparza has been associated with adverse reactions generally of mild or moderate severity and generally not requiring treatment discontinuation.
As for the most frequently observed adverse reactions across clinical trial in patients receiving Lynparza monotherapy were nausea, fatigue/asthenia, anemia, vomiting, diarrhea, decreased appetite, headache, neutropenia, dysgeusia, cough, leukopenia, dizziness, dyspnea, and dyspepsia.
“We are delighted that olaparib has been authorised by the MHRA today, opening a new chapter in prostate cancer treatment. This additional therapy option supports our overall ambition to reduce the national burden of prostate cancer and we are continuing to work with NICE and NHS England to secure access as quickly as possible for patients. Medical advances like these offer hope of further progressing the UK as a leader in life science,” said Ed Piper, Medical and Scientific Affairs director, AstraZeneca UK, in a press release.
“Prostate cancer is the most common cancer in men in the UK and advanced prostate cancer is associated with a significant mortality rate. This approval from the MHRA marks important progress in advancing a new treatment option to address the significant unmet need of patients with metastatic castration-resistant prostate cancer,” said David Long, Head of Oncology at MSD UK, in the release.