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FDA approves Janssen’s AKEEGA to treat prostate cancer
2023-08-14
临床结果临床3期上市批准
AKEEGA is intended for the treatment of metastatic castration-resistant prostate cancer. Credit: Chinnapong/Shutterstock.com.
AKEEGA Food and Drug Administration (FDAmetastatic castration-resistant prostate cancernies of Johnson & Johnson’s AKEEGA for treating patients with metastatic castration-resistant prostate cancer (mCRPC).
A once-Food and Drug Administration (FDA)omprises a highly Janssen Pharmaceutical CompaniesmeraJohnson & JohnsonapaAKEEGAnd an androgen biosynthesis metastatic castration-resistant prostate cancer (mCRPC)
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View allCompanies IntelligenceJanssen IncProstate Cancer
It is indicated with prednisone to treat adults with mCRPC and BRCA[a specific cancer gene]-positive mutations.
AKEEGA is available in 200mgTivozanib Hydrochloride000mProstate Cancercetate dosages. The high dosage is the recommended starting dose while the low dosage is available for dose reduction.
The approval is based on positive results from the Phase III MAGNITUDE study that evaluated the combination therapy.
In the multi-centre, prednisonentrolled, double-blindmCRPCdomised study, a statcancerlly significant risk reduction of 47% was observed for radiographic progression-free survival (rPFS) in BRCA-positive patients.
AKEEGAfety profile of the combined therniraparib/1,000entabiraterone acetatefile of each monotherapy approved by the FDA, with serious adverse events (AEs) reported in 41% of patients.
More than 20% of patients experienced the most common AEs: nausea, constipation, fatigue, hypertension and musculoskeletal pain. 15% permanently discontinued due to an adverse reaction.
Janssen research and development (solid tumours) clinical development vice-president Kiran Patel stated: “Janssen’s legacy of advancing the science of prostate cancer has contributed to the evolution of transformational treatment approaches for more than a decade.
“This milestone, which marks the approval of Janssen’s third prostate cancer treatment, highlights the importance of FDAancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC.”
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