(Sharecast News) - AstraZeneca and MSD's Lynparza prostate cancer drug has been granted conditional approval in China after a successful phase three trial, the companies said on Thursday.
The approval by China's National Medical Products Administration was based on a subgroup analysis of the trial, which showed that Lynparza demonstrated a "substantial improvement" patients with germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer.
Continued approval is contingent upon verification and description of clinical benefit in a planned bridging trial with Chinese patients, they added.
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 companies added.
Astrazeneca (AZN)26 Apr 2024 09:33
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