AstraZeneca and MSD’s Lynparza has received conditional approval in China for the treatment of patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).
The approval by China’s National Medical Products Administration was based on a Phase III trial results which showed that Lynparza demonstrated a substantial improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus abiraterone or enzalutamide in men with BRCA1/2 mutations.
Continued approval is contingent on clinical benefit trials with Chinese patients.
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “This approval begins a new era of precision medicine for patients in China with advanced prostate cancer who have historically had a poor prognosis and few treatment options.
“Lynparza more than tripled radiographic progression-free survival in the PROfound trial and is the only PARP inhibitor to show an overall survival benefit compared to treatment with new hormonal agents for men with BRCA-mutated metastatic castration-resistant prostate cancer.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “The approval underscores the critical importance of BRCA testing in men with prostate cancer.
“We are proud to provide a new personalised treatment option for men with this devastating disease in China, and we will continue to collaborate with the Chinese government and healthcare organisations to bring Lynparza to patients who need it.”
In China, prostate cancer is the sixth most prevalent cancer in men, with approximately 115,000 new patients diagnosed each year and about 7% have germline BRCA mutations.
Prostate cancer patients with these mutations are more likely to have poorer outcomes than those without the mutations.
Around 70% of prostate cancer patients in China have advanced disease at the time of diagnosis, and for those with mCRPC, the median survival is less than two years.
The subgroup analysis from the PROfound Phase III trial showed Lynparza reduced the risk of disease progression or death by 78%.
This is a syndicated feed from Pharmafile