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FDA approval decision expected in the second quarter of 2020.
The FDA has granted Priority Review to AstraZeneca’s supplemental New Drug Application (sNDA) for olaparib (Lynparza) for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC), according to a press release.
If approved, olaparib would be indicated to treat patients with mCRPC and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutation, who have progressed following prior treatment with a new hormonal agent.
Prostate cancer is the second most common cancer in men and mCRPC occurs when the disease grows and spreads to other parts of the body despite the use of androgen-deprivation therapy. Although the number of available therapies for mCRPC has increased, 5-year survival remains low, according to AstraZeneca.
Olaparib is a poly ADP ribose polymerase (PARP) inhibitor designed to block DNA damage response in cells and tumors harboring a deficiency in HRR, such as mutations in BRCA1 and/or BRCA2.
Data from the phase 3 PROfound trial, which were presented at the 2019 European Society of Medical Oncology congress, demonstrated significant reduction of the risk of disease progression or death with olaparib. Compared with abiraterone or enzalutamide in patients with BRCA1/2 or ATM-mutated mCRPC, olaparib showed a 66% risk reduction based on a hazard ratio of 0.34 (p<0.0001), according to the study.2
Additionally, olaparib also reduced the risk of disease progression or death by 51% based on a hazard ratio of 0.49 (p<0.0001) versus abiraterone or enzalutamide in the overall trial population of patients with HRR-mutated mCRPC.2
The safety and tolerability of olaparib was similar to that observed in prior clinical trials. The most common adverse events were anemia, nausea, fatigue/asthenia, decreased appetite, and diarrhea.2
According to AstraZeneca, the PROfound trial is the first positive phase 3 study testing a targeted treatment in biomarker-selected prostate cancer patients.
Olaparib is currently approved for the treatment of other cancer types, including advanced ovarian cancer, metastatic breast cancer, and metastatic pancreatic cancer.
A Prescription Drug User Fee Act (PDUFA) date for the sNDA is set for the second quarter of 2020.