The US FDA approves Roche's PD-L1 inhibitor

Science

Roche has recently proclaimed that the US Food and Drug Administration (FDA) has approved its PD-L1 inhibitor, for the treatment of specific melanoma in patients.

MEK inhibitor Cotellic, plus BRAF inhibitor Zelboraf and Tecentriq, has been supported for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The BRAF protein is mutated in approximately fifty-per cent of all melanoma patients.

“Roche has recently proclaimed that the US Food and Drug Administration (FDA) has approved its PD-L1 inhibitor, for the treatment of specific melanoma in patients.“

The approval follows the findings of the Tecentriq combination phase III Imspire150 trial by Roche, where the drug enhanced median progression-free-survival, which showed a fifteen-point-one month PFS, compared to ten-point-six months in the placebo arm.

Roche’s Genentech division’s Head of Global Product Development and Chief Medical Officer, Levi Garraway, stated: "When receiving cancer immunotherapy combined with targeted therapies, patients with BRAF V600 mutation-positive advanced melanoma were able to live for more than fifteen months without their disease worsening. The FDA approval of this Tecentriq combination represents an important step forward for many patients living with advanced melanoma.”

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