Roche withdraws Tecentriq and Avastin RCC submission
Admitting that its trial results are not strong enough, Roche (ROG: SIX) has told the European Medicines Agency (EMA) not to consider a type II variation to extend the use of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab).
The Swiss pharma giant had been seeking a label extension for the combination of its two drugs to treat unresectable locally-advanced or metastatic renal cell carcinoma (RCC) patients whose tumors have a PD-L1 expression of at least 1%.
Tecentriq, a PD-L1 inhibitor, has been approved in a couple of cancer indications and Roche has been keen to prove its worth alongside the anti-VEGF drug Avastin, but results from the IMmotion151 trial are not strong enough to support the RCC application at present, the company has decided.
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