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Johnson & Johnson Seeks the EC’s Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

The EMA has received an application for label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone to treat adults with mHSPC & HRR gene alterationsSubmission was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered…
July 4, 2025

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J&J Presents P-III (AMPLITUDE) Trial Data of Akeega for Metastatic Castration-Sensitive Prostate Cancer (mCSPC) at ASCO 2025

Shots:The P-III (AMPLITUDE) trial assessed Akeega (niraparib & abiraterone acetate tablet) + prednisone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mCSPC, meeting its 1EP of improved rPFSIn BRCA-altered pts (n=191), trial showed a 48% & 56% reduction in rPFS & symptomatic progression risk, respectively,…
June 4, 2025

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Insights+: EMA Marketing Authorization of New Drugs in February 2023
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in February 2023

Shots:The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industryIn February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndromePharmaShots has compiled…
March 23, 2023

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