Will Lynparza, a targeted anti-cancer drug for prostate cancer, expand prescription?

The scope of combination prescription of Lynparza (ingredient: olaparib), a prostate cancer-targeted anticancer drug, is expected to expand.

The U.S. Food and Drug Administration (FDA) has approved an expanded indication of AstraZeneca’s PARP inhibitor Lynparza combination therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) with a BRCA gene mutation on the 1st (local time). Through this, a combination therapy of Lynparza, Zytiga (ingredient: abiraterone), and prednisolone is available for the patient.

The expansion of this indication was made based on the results of the PROpel study, a global phase 3 clinical trial. According to the main results, Lynparza combination therapy showed a statistically significant reduction of 34% compared to abiraterone in the risk of radiological disease progression or death in mCRPC patients.

The median radiographic progression-free survival (PFS), which is a criterion for determining benefits following chemotherapy, was confirmed to be 24.8 months and 16.6 months in the Lynparza combination group and the abiraterone treatment group, respectively. In addition, as a result of the final overall survival (OS) analysis, the median overall survival of the Lynparza, abiraterone and prednisolone combination group was 42.1 months, ahead of the abiraterone + placebo group of 34.7 months.

The safety and tolerability of the combination of Lynparza and abiraterone were consistent with the results observed in previous clinical trials and with known drug profiles for individual drugs.

Prostate cancer is the second most common cancer in men, and mCRPC refers to an advanced stage in which cancer cells that do not respond to hormone therapy remain. Exposure to male hormones at this stage can exacerbate the disease, so hormones must be maintained at castration levels.

Currently, mCRPC standard drug therapy uses taxel-based anticancer drugs in combination with abiraterone and angelutamide. However, the chemotherapy treatment has the disadvantage of severe side effects compared to hormone treatment. In this situation, Lynparza is evaluated as a therapeutic alternative for mCRPC patients with BRCA mutations.

In October 2021, Lynparza was approved by the Ministry of Food and Drug Safety in Korea as a treatment for adult patients with BRCA-mutated mCRPC who had progressed disease after previous treatment with a new hormone therapy.