Roche to refile subcutaneous Tecentriq application with FDA before year’s end on the back of manufacturing tweaks

Roche plans to file a new ap­pli­ca­tion to the FDA by the end of the year for its sub­cu­ta­neous ver­sion of Tecen­triq, a spokesper­son told End­points News. The spokesper­son did not di­rect­ly an­swer whether Roche pulled its pre­vi­ous ap­pli­ca­tion or if its cur­rent ap­pli­ca­tion is still with the FDA, on­ly re­it­er­at­ing it in­tends to file a new ap­pli­ca­tion.

“We did not re­ceive a re­jec­tion (com­plete re­sponse let­ter or re­jec­tion to file). We are mak­ing these up­dates in line with the FDA re­quire­ments,” the spokesper­son not­ed.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.