US FDA tightens ship on Accelerated Approval scheme

8 March 2021

A third pharma major in as many weeks has voluntarily withdrawn from an immuno-oncology indication, as the US regulator toughens its stance towards Accelerated Approvals.

The US indication in question is for Tecentriq (atezolizumab), in prior-platinum treated metastatic urothelial carcinoma.

Swiss cancer giant Roche (ROG: SIX) was granted an Accelerated Approval for these patients in 2016, on the basis of results from the IMvigor210 study.

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