Characterization and survival benefit of drugs approved for metastatic prostate cancer.

81 Background: The treatment landscape of metastatic prostate cancer (mPC) drastically changed with the approval of chemotherapy (docetaxel) in 2004, and novel hormonal therapy (NHT) abiraterone in 2011. Since then, several other therapies have been approved in the metastatic castrate-sensitive (mCSPC) and -resistant (mCRPC) settings. Despite multiple drug approvals, it remains unclear how much improvement in survival these therapies have provided. Methods: We reviewed the US Food and Drug Administration (FDA) website to evaluate all approvals for prostate cancer from 2004 to 2022. We collected progression-free survival (PFS) and overall survival (OS) from the approval notification or from the corresponding clinical trial cited for drug approval. Results: Between 2004 and 2022, there were 14 drug (single or combination) approvals for mPC. Most approvals (81.3%) were granted through regular approval. Average PFS benefit for mCSPC was 4.8 months and average OS benefit for mCSPC was not reached in ongoing trials. Average PFS benefit for mCRPC was 3.7 months (range 1.9-5.4) and average OS benefit for mCRPC was 3.67 months. Conclusions: Despite 14 drug (single or combination) approvals for mPC since 2004, the improvements in average PFS and OS were modest in both castrate-sensitive and -resistant settings. OS data for several NHTs continues to mature, and may alter average OS benefits once median OS is reached. Nonetheless, continued drug development for mPC is warranted. [Table: see text]