Olaparib Gains BRCA-Mutated Prostate Cancer Indication

The US Food and Drug Administration (FDA) has approved olaparib (Lynparza, AstraZeneca) with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.

The PARP inhibitor already carries indications for ovarian, breast, and pancreatic cancer, as well as homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer that has progressed on enzalutamide (Xtandi) or abiraterone.

Approval for the new indication was based on the PROpel trial in men with metastatic castration-resistant prostate cancer. In the 85 subjects with BRCA-mutated disease, median radiological progression-free survival and overall survival were not reached when olaparib was added to abiraterone and prednisone or prednisolone compared with 8 months and 23 months, respectively, among men randomized to placebo instead of olaparib, according to an FDA press release.

The results “showed the Lynparza combination demonstrated a notable, clinically meaningful benefit that should rapidly be considered as the standard of care treatment for patients” with BRCA-mutated metastatic castration-resistant prostate cancer, said investigator Andrew Armstrong, MD, a medical oncologist at Duke University in Durham, North Carolina, in a press release from Merck, which collaborated with AstraZeneca to commercialize the agent.

The most common adverse reactions with olaparib plus abiraterone were anemia (48%), fatigue (38%), nausea (30%), diarrhea (19%), decreased appetite (16%), lymphopenia (14%), dizziness (14%), and abdominal pain (13%); 18% of patients required at least one blood transfusion and 12% required multiple transfusions.

The recommended olaparib dose is 300 mg taken orally twice daily with or without food. The recommended abiraterone dose is 1000 mg taken orally once daily. Abiraterone should be administered with prednisone or prednisolone 5 mg orally twice daily. Patients should also receive a GnRH analog concurrently or should have had a prior bilateral orchiectomy.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: [email protected] .

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