Express approval of immune checkpoint inhibitors: a conflict between science and finance

Immune checkpoint inhibitors are new biologic agents currently in the process of revolutionizing cancer care. By blocking pro-inhibitory agents of the immune response, these agents allow for a restitution of the cancer-killing properties of the immune system which will no longer be limited by the tumor’s ability to evade detection. Different agents (anti-CTLA4, anti-PD-1 and anti-PD-L1) were approved in the past few years for different malignancies and in different settings.

The US FDA has already approved immune checkpoint inhibitors for the treatment of malignant disease in eight different settings with five approvals gained during the present year, namely in melanoma and non-small-cell lung cancer (NSCLC). In 2011, ipilimumab was the first immune checkpoint inhibitor to be approved in BRAF nonmutated metastatic melanoma [1]. Recently, ipilimumab has gained approval in the adjuvant setting of melanoma and in combination with nivolumab in first-line BRAF nonmutated metastatic melanomas [2]. This ‘snow-ball’ of approvals will most likely increase in volume and velocity during the upcoming years, since more than hundreds of ongoing trials are evaluating the efficacy of different checkpoint inhibitors, namely, anti-PD1 and anti-PD-L1 agents.

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