Opdivo®, nivolumab, is anti cancer drug, a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of:
- Unresectable or Metastatic Melanoma – Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma
- Adjuvant Treatment of Melanoma – Opdivo is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
- Metastatic Non Small Cell Lung Cancer – Opdivo is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo
- Small Cell Lung Cancer – Opdivo is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- Advanced Renal Cell Carcinoma – Opdivo as a single agent is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy
- Opdivo, in combination with ipilimumab, is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC)
- Classical Hodgkin Lymphoma – Opdivo is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:
* autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or
* 3 or more lines of systemic therapy that includes autologous HSCT.
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see Clinical Studies - Squamous Cell Carcinoma of the Head and Neck – Opdivo is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy
- Urothelial Carcinoma – Opdivo (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
* have disease progression during or following platinum-containing chemotherapy
* have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration
of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials - Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient(dMMR) Metastatic Colorectal Cancer
- Opdivo, as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- Opdivo, in combination with ipilimumab, is indicated for the treatment of adults and pediatric patients 12 years and older with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
- Hepatocellular Carcinoma – Opdivo is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials
