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Lutathera’s Broad Tumor Indication Aided By Expanded Access Data

 
• By Sue Sutter

US FDA’s approval of Advanced Accelerator Applications’ radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors was driven by robust Phase III study results in midgut carcinoid tumors and data from an investigator-initiated, expanded access study in the Netherlands that enrolled patients with a host of other neuroendocrine tumor types.

Drug Review Profile regular column

Amid the ongoing US debate about whether patients should have a statutory right to try investigational drugs, expanded access programs and emergency use requests factored into two recent US FDA approvals in diseases with high unmet needs.

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More from Drug Review Profiles

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
• By Bridget Silverman

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

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