More I-O early approvals bear scrutiny of FDA review
There was more good news for Swiss company Roche (ROG: SIX) on Wednesday, as the US regulator’s scientific panel voted to maintain another Accelerated Approval for Tecentriq (atezolizumab).
The panel voted 10 to one in favor of keeping the approval, despite a lack of confirmatory data, for certain people with locally advanced or metastatic urothelial carcinoma, or bladder cancer.
On Tuesday the panel voted to keep another such early approval in place for the checkpoint blocker, in breast cancer. The Food and Drug Administration is expected to follow the recommendations.
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