British drug major AstraZeneca Plc (AZN.L,AZN) announced Tuesday that the U.S. Food and Drug Administration has accepted and granted Priority Review to the supplemental New Drug Application or sNDA for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone.
The sNDA is for the treatment of adult patients with metastatic castration-resistant prostate cancer or mCRPC.
Lynparza is being jointly developed and commercialised by AstraZeneca and Merck & Co., Inc. (MRK).
The sNDA was based on results from the PROpel Phase III trial presented at the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and later published in NEJM Evidence.
These results showed Lynparza in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone .
The FDA grants Priority Review to applications for medicines that offer significant advantages over available options. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2022.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, "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. ...If approved, Lynparza with abiraterone will become the first combination of a PARP inhibitor and a new hormonal agent for patients with this disease."
Lynparza is approved in the US for patients with HRR gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone.
It is approved 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 PROfound Phase III trial.
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