The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
On 31 May, the FDA granted approval based on subgroup analysis of the Phase III PROpel trial (NCT03732820) in patients with BRCA mutations. In a subgroup of patients with germline BRCA mutations treated with Lynparza, Janssen Oncology’s Zytiga (abiraterone) and prednisone, the median radiographic progression-free survival (rPFS) overall survival (OS) was not yet reached. In comparison, the rPFS and OS for those on placebo with Zytiga and prednisone was 8 months and 23 months, respectively.
Safety and tolerability were in line with that observed in prior trials and the known profiles of the medicines.
The PROpel study included 796 mCRPC patients who had not received prior chemotherapy or NHAs in the mCRPC setting. A prior orchiectomy or receipt of gonadotropin-releasing hormone (GnRH) analogs was also necessary.
Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, claimed that these results can satisfy a critical unmet need for new BRCAm mCRPC treatments.
Prostate cancer is the second-most common cancer reported in men. The five-year survival rates for mCRPC patients is poor, and paired with a worse prognosis for the 10% of patients with BRCAm, new treatments are necessary in this space.
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According to figures from GlobalData’s clinical trials database, research into mCRPC treatments has been on the rise over the past 10 years. Trials peaked at 115 in 2018 before declining to 91 last year. So far, 68 trials have been initiated in 2023.
GlobalData is the parent company of Pharmaceutical Technology.
This latest approval follows a series of successful results for the PARP inhibitor over the past few years. Different countries have approved for a range of cancer treatments, including in breast, prostate and ovarian cancers. Trials are also underway to study Lynparza’s ability to treat lung, pancreatic and bile duct cancers.