Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer
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Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer

First PARP inhibitor and new hormonal agent combination approved for these patients in Europe

  • By IPP Bureau | December 22, 2022

AstraZeneca and Merck announced that LYNPARZA has been approved in the European Union (EU) 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.

This approval by the European Commission follows the positive recommendation from the Committee for Medicinal Products for Human Use received in November this year and was based on the Phase 3 PROpel trial, results of which were published in NEJM Evidence in June 2022.

Noel Clarke, urological surgeon and professor of urological oncology at Manchester’s Christie/Salford Royal Hospitals and Manchester University, a senior investigator of the PROpel trial, said, “The results of the PROpel Phase 3 trial of olaparib in combination with abiraterone as a first-line treatment show that this therapeutic combination can provide significant clinical benefit to patients with mCRPC. Patients with this condition in the EU will now, for the first time, have the opportunity to benefit from this new treatment combination.”

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “Many patients with mCRPC are only able to receive one line of active therapy, as the disease can progress quickly. LYNPARZA in combination with abiraterone has been shown to reduce the risk of disease progression by 34% versus the standard of care treatment in the PROpel trial. Moreover, the combination of LYNPARZA with abiraterone as a first-line treatment expands the use of LYNPARZA to a broader group of mCRPC patients than those treated with LYNPARZA alone in the second-line setting in the PROfound trial. Today’s approval marks a significant advance toward addressing the unmet need of patients with mCRPC in the EU.”

Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “Merck is committed to developing new treatment options for patients with mCRPC, a complex disease that urgently needs more therapies. This approval by the European Commission marks another step toward delivering on that commitment, and we look forward to extending the benefits of LYNPARZA to more patients with mCRPC in the EU.”

Use of LYNPARZAin combination with abiraterone and prednisone or prednisolone is currently under review by the U.S. FDA for the treatment of adult patients with mCRPC. LYNPARZA is approved in the U.S. as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone and in the EU, Japan and China for patients with BRCA-mutated mCRPC who have progressed following prior therapy that included a new hormonal agent (NHA). These approvals were based on the data from the Phase 3 PROfound trial.

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