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Lynparza recommended for approval in EU for BRCA-mutated metastatic castration-resistant prostate cancer

José Baselga

AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a subgroup analysis of patients with BRCA1/2 mutations from the PROfound Phase III trial. The primary results from the trial were published in The New England Journal of Medicine in May 2020.

“Patients diagnosed with metastatic castration-resistant prostate cancer unfortunately have few treatment options and historically a poor prognosis. This recommendation for Lynparza brings us closer to making the only PARP inhibitor to improve overall survival in this setting available to men in the EU. BRCA testing should now become a critical step in the diagnosis and determination of treatment for men with advanced prostate cancer in the EU,” says José Baselga, Executive Vice President, Oncology R&D, AstraZeneca.

Regulatory reviews are ongoing in other countries around the world

The CHMP recommendation for Lynparza is for the treatment of adult patients with mCRPC and BRCA1/2 mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

Lynparza was approved in the US for men with HRR gene-mutated mCRPC in May 2020 based on the PROfound Phase III trial. Regulatory reviews are ongoing in other countries around the world.

AstraZeneca and MSD are exploring additional trials in metastatic prostate cancer including the ongoing PROpel Phase III trial testing Lynparza as a 1st-line treatment for patients with mCRPC in combination with abiraterone versus abiraterone alone. Data are anticipated in the second half of 2021.

Photo of José Baselga: AstraZeneca