Policy & Regulation
Genentech reports FDA approval of Tecentriq combination for advanced melanoma
31 July 2020 -

Genentech, part of the Roche Group (SIX:RO (SIX:ROG) (OTCQX:RHHBY), revealed on Thursday that the US Food and Drug Administration (FDA) has approved a Tecentriq (atezolizumab) combination therapy for people with advanced melanoma.

Tecentriq plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) was approved for the treatment of BRAF V600 mutation-positive advanced melanoma patients.

The approval was based on results from the Phase III IMspire150 study, which showed that the addition of Tecentriq to Cotellic and Zelboraf helped people live longer without their disease worsening or death (progression-free survival), compared to placebo plus Cotellic and Zelboraf.

The supplemental Biologics License Application (sBLA) for Tecentriq was granted under Priority Review.

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