FDA extends US approval for olaparib in prostate cancer

Male patient with doctor

Lynparza (olaparib) has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).

The PARP inhibitor, developed by AstraZeneca and Merck (MSD), is approved in combination with abiraterone and prednisone or prednisolone.

This approval was based on a subgroup analysis of the Phase III PROpel trial. The combination therapy was found to reduce the risk of disease progression or death by 76% vs. abiraterone alone.

Andrew Armstrong of the Duke Cancer Institute, Durham, North Carolina, US, and an investigator in the trial, said: “Preventing or delaying radiographic progression or death is an important clinical endpoint in assessing cancer treatment and is very important to patients, their caregivers, and their families. The PROpel results showed the Lynparza combination demonstrated a notable clinically meaningful benefit that should rapidly be considered as the standard of care treatment for patients with BRCA-mutated metastatic castration-resistant prostate cancer.”

Lynparza in combination with abiraterone and prednisone or prednisolone is approved in the European Union (EU) and several other countries for the treatment of adult patients with mCRPC based on the PROpel trial.

The drug is already approved in the US based on results from the PROfound Phase III trial as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCAm and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone.

It is approved in the EU, Japan, and China for patients with BRCAm mCRPC who have progressed following prior therapy that included a novel hormonal agent.

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