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Vitrakvi, Daurismo Approvals Put US FDA On Brink Of Another Record

 
• By Bridget Silverman

New oncologics bring CDER’s novel agent approvals count to 53 for the year.

Group of happy business people running from office building crossing red ribbon finish line
US FDA is on the cusp of a record-breaking approval year.

The US FDA bracketed the Thanksgiving holiday with two new molecular entity approvals (NMEs) in oncology – Pfizer Inc.’s Daurismo (glasdegib) on Nov. 21 and Loxo Oncology Inc. and Bayer AG’s Vitrakvi (larotrectinib) on Nov. 26 – bringing the Center for Drug Evaluation and Research’s (CDER's) novel agent count for 2018 to a record-tying 53 approvals.

CDER is likely to reach 54 approvals by the end of November, further solidifying 2018 as the best year ever for clearance of NMEs and novel therapeutic biologics. In late October, CDER blew past the previous record for the center in its contemporary configuration of review responsibilities, set by the 46 novel agents approved in all of 2017

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New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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.

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