AstraZeneca and MSD announce MHRA marketing authorisation of Lynparza combination therapy

pharmafile | March 20, 2023 | News story | Medical Communications  

AstraZeneca and MSD have announced that the MHRA has granted marketing authorisation for Lynparza (olaparib) in the UK, when used in combination with abiraterone and prednisone or prednisolone, to treat metastatic castration-resistant prostate cancer (mCRPC) in patients for whom chemotherapy is not recommended.

According to the companies’ press release, at least 52,000 men are diagnosed with prostate cancer each year in the UK, equaling upwards of 140 cases each day. 10-20% of these patients will develop castration-resistant prostate cancer (CRPC) within five years, meaning the cancer becomes resistant to androgen deprivation therapy (ADT).

This approval followed results from the PROpel phase 3 trial, which showed that the drug in combination with abiraterone significantly improved radiographic progression-free survival (rPFS) compared to abiraterone alone as a first-line treatment.

Professor Noel Clarke, professor of urological oncology at The Christie and Salford Royal Hospital, commented: “This approval by the MHRA is an important next step for healthcare professionals and their patients in the UK with this specific type of prostate cancer. This data from the PROpel phase 3 trial underlines the therapeutic potential of new first-line treatment options for patients with metastatic castration-resistant prostate cancer, especially given that many have a much-shortened life-span when their disease becomes castration-resistant.”

Ed Piper, medical and scientific affairs director at AstraZeneca, added: “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.”

David Long, head of oncology at MSD UK, said: “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.”


Betsy Goodfellow

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