New Prostate Cancer Indication for Lynparza

May 20, 2020 – The U.S. FDA has approved a new indication for Lynparza® (olaparib), manufactured by AstraZeneca and Merck, to treat adult patients who have deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) and who have progressed following prior treatment with enzalutamide or abiraterone.

An estimated 43,000 men in the United States will be diagnosed with mCRPC in 2020. Although prostate cancer is curable when identified early, patients diagnosed with castration-resistant prostate cancer face a high risk of incurable metastatic disease. Approximately 20-30% of patients with mCRPC possess HRR gene mutations that may respond to treatment with PARP inhibitors like Lynparza.

In a clinical trial, Lynparza reduced the risk of disease progression or death by 51% and delivered a median progression-free survival time of 5.8 months compared to 3.5 months with enzalutamide or abiraterone. In men with mCRPC who had BRCA1/2 or ATM gene mutations, Lynparza reduced the risk of death by 31% and improved overall survival to a median of 19.1 months compared to 14.7 months with enzalutamide or abiraterone.

Recommended dosing is 300mg taken twice daily by mouth, with or without food. Treatment should continue until disease progression or unacceptable toxicity occur. Dosage adjustment may be required based on individual patient factors, such as renal health and other medications the patient may be taking. Patients on Lynparza for mCRPC should also receive concurrent treatment with gonadotropin-releasing hormone (GnRH) analog or have undergone a bilateral orchiectomy.

Originally FDA approved in 2014, Lynparza is also indicated to treat ovarian cancer, breast cancer, and pancreatic cancer.