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Roche Forced To Wait By FDA For SC Tecentriq Okay

Seven-Minute Injection Recently Approved In UK

 
• By Kevin Grogan

The Swiss major’s partner Halozyme has revealed that the US launch for the subcutaneous version of the checkpoint inhibitor Tecentriq will be put back until 2024 following questions from the Food and Drug Administration about manufacturing processes.

SubQ
• Source: Shutterstock

A fortnight after celebrating the first global green light, in the UK, for the subcutaneous (SC) version of Tecentriq, Roche Holding AG's plans for a swift US approval for its anti-PD-L1 cancer immunotherapy have hit a bump in the regulatory road.

The US Food and Drug Administration had set a 15 September user fee goal date for the SC formulation of...

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