FDA Grants Priority Review to Lynparza-Based Combination for Metastatic Prostate Cancer

The Food and Drug Administration (FDA) has granted Lynparza (Olaparib) in combination with Zytiga (abiraterone) and the steroid prednisone or the steroid prednisolone alone priority review for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC), according to a press release from AstraZeneca, the drug’s manufacturer.

The FDA grants priority reviews to investigational drugs that, if approved, may be a significant improvement over the standard-of-care therapy.

The decision was based off results of the phase 3 PROpel trial that were presented at the 2022 ASCO Genitourinary Cancers Symposium. The data showed a 34% reduction in risk for disease progression or death with the combination compared with Zytiga alone. Additionally radiographic progression-free survival (an endpoint that represents a clinically meaningful benefit to the patient) was 24.8 months versus 16.6 months, respectively.

“There remains a critical unmet need among patients diagnosed with metastatic castration-resistant prostate cancer, where the prognosis remains poor and treatment options are limited,” said Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, in the release.

About 10% to 20% of patients with advanced prostate cancer will develop castration-resistant prostate cancer within five years, and at least 84% of that will metastasize (spread), according to the release. And despite the advances in treatment for this population, there is still a high unmet need for this population.

“Today’s news is another step towards bringing forward a new, much-needed treatment option in this setting,” Galbraith added. “If approved, Lynparza with (Zytiga) will become the first combination of a PARP inhibitor and a new hormonal agent for patients with this disease.”

The safety profile with Lynparza plus Zytiga was consistent with what previous clinical trials reported of each individual medicine.

Lynparza is currently FDA-approved in the United States for patients with BRCA-mutated or other HRR gene mutated mCRPC who have progressed following previous treatment with Xtandi (enzalutamide) or Zytiga.

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