[11] In May 2021, the FDA approved nivolumab for the treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease after neoadjuvant chemoradiotherapy.
[12] In August 2021, the FDA approved nivolumab for the adjuvant treatment of urothelial carcinoma who are at high risk of recurrence after undergoing radical resection.
[22] In March 2024, the FDA approved nivolumab, in combination with cisplatin and gemcitabine, as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma.
[23][24] In October 2024, the FDA approved nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
[27] In trials for melanoma, the following side effects occurred in more than 10% of subjects and more frequently than with chemotherapy alone: rash and itchy skin, cough, upper respiratory tract infections, and peripheral edema.
Other clinically important side effects with less than 10% frequency were ventricular arrhythmia, inflammation of parts of the eye (iridocyclitis), infusion-related reactions,[vague] dizziness, peripheral and sensory neuropathy, peeling skin, erythema multiforme, vitiligo, and psoriasis.
[28][29] Normally, certain cancer cells exploit the PD-1 pathway to shield themselves from the immune response by expressing programmed death-ligand 1 (PD-L1), which interacts with the PD-1 receptor and inhibits T-cell activation and proliferation.
This blockade enhances T-cell response, boosts the immune system's anti-tumor activity, and ultimately contributes to the destruction of cancer cells.
[38] In May 2016, the FDA approved nivolumab for the treatment of people with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.
[39] In December 2017, the FDA granted approval to nivolumab for adjuvant treatment of melanoma with involvement of lymph nodes or for metastatic disease with complete resection.
[40] In April 2018, the FDA granted approval to nivolumab in combination with ipilimumab for the first-line treatment of people with intermediate and poor risk advanced renal cell carcinoma.
[42] In October 2020, the US Food and Drug Administration (FDA) approved the combination of nivolumab with ipilimumab for the first-line treatment of adults with malignant pleural mesothelioma (MPM) that cannot be removed by surgery.
[11] In March 2024, the FDA approved nivolumab, in combination with cisplatin and gemcitabine, for first-line treatment of adults with unresectable or metastatic urothelial carcinoma.
[16] In 2016, Bristol Myers Squibb announced the results of a clinical trial in which nivolumab failed to achieve its endpoint and was no better than traditional chemotherapy at treating newly diagnosed lung cancer.
[47] Bristol Myers Squibb went on to attempt to gain approval for a combination therapy for lung cancer that included nivolumab and the company's older drug ipilimumab.
[9] CHECKMATE-227[50] tested the combination of nivolumab and ipilimumab in participants with stage IV or recurrent non-small cell lung cancer without previous treatment.
[51][50] The chemotherapeutics used were cisplatin or carboplatin combined with gemcitabine for people with squamous-cell non-small cell lung cancer, or pemetrexed for those with nonsquamous disease.
[54] Phase I and II clinical trials have shown nivolumab as a promising and durable treatment option in melanoma as a single agent and in combination with ipilimumab.
[55] In October 2022, the results of a phase III trial, CheckMate -76K, showed that Opdivo reduced the risk of death by 58% as an adjuvant therapy in participants with completely resected stage two melanoma, the most serious type of skin cancer.