History[edit]
PD-1 was first shown to be an immune checkpoint in 2000.[6]
Nivolumab was created by scientists at Medarex using Medarex's transgenic mice with a humanized immune system; the discovery and in vitro characterization of the antibody, originally called MDX-1106, was published in 2014.[7] Medarex licensed Japanese rights to nivolumab to Ono Pharmaceutical in 2005.[8] Bristol Myers Squibb acquired Medarex in 2009 for $2.4B, largely on the strength of its checkpoint inhibitor program.[9][10]
Promising clinical trial results made public in 2012 caused excitement among industry analysts and in the mainstream media; PD-1 was being avidly pursued as abiological target at that time, with companies including Merck with pembrolizumab (Keytruda), Roche (via its subsidiary Genentech) with atezolizumab, GlaxoSmithKline in collaboration with the Maryland biotech company Amplimmune; and Teva in collaboration with the Israeli biotech company CureTech competing.[11][6]
Ono received approval from Japanese regulatory authorities to use nivolumab to treat unresectable melanoma in July 2014, which was the first regulatory approval of a PD-1 inhibitor anywhere in the world.[8]
Merck received its first FDA approval for its PD-1 inhibitor, Keytruda, in September 2014.[12]
Nivolumab received FDA approval for the treatment of melanoma in December 2014.[3][13] In April 2015, the Committee for Medicinal Products for Human Use of theEuropean Medicines Agency recommended approval of Nivolumab for metastatic melanoma as a monotherapy.[14]
In March 2015 the US FDA approved it for the treatment of squamous non-small cell lung cancer.[15]
In November 2015 the FDA approved nivolumab as a second-line treatment for renal cell carcinoma after having granted the application breakthrough therapy designation,fast track designation, and priority review status.[16]
In May 2016, the FDA approved nivolumab for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.[17]
