Immune checkpoint blockade

Targeting the immune system instead of the cancer cells, these new drugs are revolutionizing the treatment of cancer.

More specifically, proteins of the immune-checkpoint pathways on the surface of T cells play important roles in the development of immune tolerance. Cytotoxic T-lymphocyte antigen 4 (CTLA-4) signaling for instance, inhibits T-cell activation. Thus CTLA-4 blockade using anti-CTLA-4 monoclonal antibody therapy has great potential because suppression of inhibitory signals results in the generation of an antitumor T-cell response. Other important immune-checkpoint proteins are Programmed cell Death protein 1 (PD-1), and Programmed Death-Ligand 1 (PD-L1), its ligand.

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Breakthroughs in the understanding of the progression of genomic events and inflammatory microenvironment that drive premalignancy provide unprecedented possibilities to transform cancer detection and prevention and ultimately reduce cancer incidence, morbidity, and mortality. Evidence for effective drugs and vaccine strategies to prevent cancer are also mounting.

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In 2015, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 39 new active substances. One third of those were for the treatment of cancer. Like in the US, Non Small Cell Lung Cancer (NSCLC) and Melanoma benefited the most from new drugs approvals. Of the 4 new drugs approved in the US for relapsed and refractory multiple myeloma in 2015, however, only one was approved in Europe. We review here in more details newly approved oncology drugs.

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There were 17 new drugs approved in oncology by the FDA in 2015 representing 38% of all new drugs approved last year, a very significant share. 65% of new oncology drugs benefited from priority review, and 30% from Breakthrough designation. This is a clear signal of the intensity and quality of novel therapeutic approaches submitted and the fruitful collaboration between the FDA and Industry. We review here the cancers with the most new approvals.

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Recognizing that patients and physicians are generally willing to accept greater risks and side effects from treatment of life-threatening and severely debilitating diseases than they would for other diseases, the FDA established four programs: Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, and Priority Review Designation. They are widely used in Oncology. Read More