预约演示

Merck and AstraZeneca receive approval for Lynparza in Japan

2023-08-25

上市批准临床3期临床结果

Japan approved Merck and AstraZeneca’s Lynparza for use with abiraterone and prednisolone for BRCAm castration-resistant prostate cancer. Credit: Copyright © 2023 Merck & Co., Inc., Rahway, NJ USA, and its affiliates.

Merck (MSD) andMerckaZeneAstraZenecaeivLynparzaval from the JabirateroneistryprednisoloneLabor and Wcastration-resistant prostate cancerBRCA-mutated (BRCAm) castraMerck & Co., Inc.ostate cancer with distant metastasis (mCRPC) in adults.

Mercky (ADP-riboAstraZenecaase (PARP) inhibitor, Lynparza is intended for use with abiraterone and prednisolone (abi/pLynparza this indiBRCA-mutated (BRCAm) castration-resistant prostate cancer distant metastasis (mCRPC)

Repoly (ADP-ribose) polymerase (PARP)Lynparza abiraterone prednisolone

ReportsJapanese Encephalitis Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Pla... GlobalData

ReportsLOA and PTSR Model - Lipocurc in Gliosarcoma GlobalData

View alJapanese EncephalitisceAstraZeneca PlcMerck KGaAMSD KKNH&A LLCMinistry of HealthView all

The approval was based on an exploratory subgroup assessment of the double-blind, randomised Phase III PROpel clinical trial that analysed the safety, tolerability, and efficacy of Lynparza versus a placebo.

According to the trial findings, treatmeGliosarcomaparza plus abi/pred showed improvements in radiographic progression-free survival and overall survival.

The safety and tolerability of the Lynparza combination was found to be similar to that reported in previous trials and each medicine’s known profile.

AstraZeneca oncology business unit executive vice-president Dave Fredrickson said: “This Lynparza combination has been shown to reduce the risk of disease progression or death compaLynparzatandard of care and underscores the critical importance of BRCA testing at metastatic diagnosis.

“Today’s approval is a major step forward for paLynparzan Japaabiith BRCAm mCRPC who urgently need new first-line treatment options.”

The PARP inhibitor previously receiLynparzaoval in Japan for BRCAm mCRPC patients who have advanced after previous treatments comprising a new hormonal agent (NHA).

AstraZeneca oncologyroved along with abi/pred for mCRPC in adults in various countries.Lynparza

In August 2022, Merck and AstraZeneca received European Commission (EBRCAm mCRPC for Lynparza as adjuvant treatment for high-risk, early-stage breast cancer.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构