The US drugs safety regulator has fast-tracked the approval of Opdivo (nivolumab) to extend its current use to a new group of patients with advanced lung cancer.
Bristol-Myers Squibb (BMS) moves closer to approval of its checkpoint inhibitor Opdivo in kidney cancer after obtaining FDA ‘breakthrough’ status for the cancer immunotherapy in that indication. The designation comes after Opdivo (nivolumab) was shown to be effective as a treatment for renal cell carcinoma in a phase III trial reported in July.
Bristol-Myers Squibb’s (BMS’) Opdivo for the use in treatment for advanced skin cancer (unresectable or metastatic melanoma in adults) has been the first PD-1 inhibitor to gain approval by the European regulators. Last summer, the inhibitor became the first PD-1 inhibitor to be approved in the world when Japanese regulators approved it. In the US,
