LONDON (dpa-AFX) - AstraZeneca (AZN.L, AZN) and Merck & Co.'s (MRK) Lynparza or olaparib has received conditional approval in China to treat adult patients with germline or somatic BRCA-mutated metastatic castration-resistant prostate cancer or mCRPC who have progressed following treatment that included a new hormonal agent or abiraterone, enzalutamide.
The approval was based on a subgroup analysis from the PROfound Phase III trial, which showed that Lynparza reduced the risk of disease progression or death by 78% and improved radiographic progression-free survival to a median of 9.8 months versus 3.0 with abiraterone or enzalutamide in men with mCRPC with BRCA1/2 mutations.
In addition, Lynparza reduced the risk of death by 37% with median OS of 20.1 months versus 14.4 with abiraterone or enzalutamide.
Lynparza is approved in the US to treat men with homologous recombination repair gene-mutated (HRRm) mCRPC and in the EU, Japan and several other countries for BRCA-mutated mCRPC patients based on the PROfound Phase III trial. In addition, regulatory reviews are ongoing in other countries around the world.
AstraZeneca and Merck are testing Lynparza in additional trials in metastatic prostate cancer, including the ongoing PROpel Phase III trial of Lynparza as a 1st-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Results are anticipated in the second half of 2021.
Copyright RTT News/dpa-AFX
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