Merck and AstraZeneca receive approval for Lynparza in Japan
25 Aug 2023
Drug ApprovalPhase 3Clinical Result
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Source: Pharmaceutical Technology
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) and AstraZeneca have received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Lynparza to treat BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC) in adults.
A poly (ADP-ribose) polymerase (PARP) inhibitorpoly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza is intended for use with abiraterone and prednisolone (abi/pred) for this indication.
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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.
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 compared to standard of care and underscores the critical importance of BRCA testing at metastatic diagnosis.
“Today’s approval is a major step forward for patients in Japan with BRCAm mCRPC who urgently need new first-line treatment options.”
The PARP inhibitor previously received approval in Japan for BRCAm mCRPC patients who have advanced after previous treatments comprising a new hormonal agent (NHA).
In August 2022, Merck and AstraZeneca received European Commission (EC) approval for Lynparza as adjuvant treatment for high-risk, early-stage breast cancer.
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