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Metastasis-Free Survival Endpoint Spreads To Labeling With US FDA Approval Of J&J's Erleada

 
• By Bridget Silverman

Apalutamide, the first drug approved to treat non-metastatic castration-resistant prostate cancer, will also be the first NDA to have clinical summary report information made public under an FDA pilot program to increase transparency.

FDA approved background, 3D rendering, blue street sign

The swift US approval of Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc.'s Erleada (apalutamide) for treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) suggests that FDA had few concerns with the pivotal trial's novel primary endpoint.

The oral androgen receptor inhibitor was approved on Feb. 14, almost two months before the new drug application's (NDA) April...

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More from Approvals

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• By Bridget Silverman

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EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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More from Product Reviews

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• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

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US FDA Pediatric Adcomm To Examine HPV, Flu, Dengue Vaccines: No News Is Good News?

 
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