AstraZeneca and Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

The CHMP based its positive opinion on results from the Phase 3 PROpel trial presented at the 2022 American Society of Clinical Oncology Genitourinary Cancers Symposium and later published in NEJM Evidence.

Noel Clarke, urological surgeon and professor of urological oncology at the Christie/Salford Royal Hospitals and University of Manchester and the PROpel trial joint senior investigator, said, “Patients with mCRPC in the European Union have limited treatment options. This form of advanced prostate cancer has a poor prognosis, and treatment decisions after initial diagnosis are critical. If approved in the European Union for prostate cancer of this type, olaparib in combination with abiraterone will provide a much-needed new treatment option for the many men with this condition.”

Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said, “With the incidence and mortality of prostate cancer set to double in the coming decades, it is more important than ever that we bring new treatment options to suitable patients at the earliest possible moment in their care. If approved, LYNPARZAin combination with abiraterone and prednisone or prednisolonewill represent the first combination of a PARP inhibitor and a new hormonal agent available to patients in the European Union.”

Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “While prostate cancer has seen many advances in care in recent decades, for those with mCRPC, new treatment options are urgently needed. We are fully committed to bringing LYNPARZAin combination with abiraterone and prednisone or prednisolone to suitable patients in Europe as quickly as possible.”

LYNPARZA in combination with abiraterone and prednisone or prednisoloneis undergoing priority review in the U.S. for the treatment of adult patients with mCRPC based on results from the Phase 3 PROpel trial, with a decision expected in Q4 2022.