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Opdivo

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For certain adults with advanced non-small cell lung cancer (NSCLC)

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread or grown, or comes back, and your tumor does not have an abnormal EGFR or ALK gene.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.

For people with previously treated advanced non-small cell lung cancer

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

For people with advanced melanoma

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous(IV) use.

For people with melanoma after it and the affected lymph nodes have been removed by surgery to prevent it from coming back

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.

For certain people with advanced kidney cancer (renal cell carcinoma)

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with kidney cancer in certain people when their cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous(IV) use.

For newly diagnosed adults whose kidney cancer (renal cell carcinoma) has spread

OPDIVO® (nivolumab) is a prescription medicine used in combination with cabozantinib to treat people with kidney cancer when your cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC. Please read the Patient Information that comes with cabozantinib.

For people with previously treated advanced kidney cancer (renal cell carcinoma)

OPDIVO® (nivolumab) is a prescription medicine used to treat people with kidney cancer (renal cell carcinoma) when your cancer has spread or grown after treatment with other cancer medications.

For people with previously treated squamous cell carcinoma of the head and neck

OPDIVO® (nivolumab) is a prescription medicine used to treat people with head and neck cancer (squamous cell carcinoma) that has come back or spread and you have tried chemotherapy that contains platinum and it did not work or is no longer working.

For people with liver cancer (hepatocellular carcinoma) that have received treatment with sorafenib

OPDIVO® (nivolumab) is a prescription medicine used to treat people with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with liver cancer (hepatocellular carcinoma) if you have previously received treatment with sorafenib. OPDIVO in combination with YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO in combination with YERVOY for this use.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous(IV) use.

For people with previously treated advanced bladder cancer (urothelial carcinoma)

OPDIVO® (nivolumab) is a prescription medicine used to treat people with bladder cancer (urothelial carcinoma) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

For people 12 years of age and older whose CRC has spread to other parts of the body (metastatic), has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and is MSI-H or dMMR

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working. OPDIVO in combination with YERVOY was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO in combination with YERVOY for this use.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous(IV) use.

OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread to other parts of the body (metastatic), is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have tried treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working. OPDIVO was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

For adults with previously treated classical Hodgkin lymphoma including an autologous stem cell transplant whose cancer has come back or spread

OPDIVO® (nivolumab) is a prescription medicine used to treat adults with a type of blood cancer called classical Hodgkin lymphoma if your cancer has come back or spread after a type of stem cell transplant that uses your own stem cells (autologous), and you used the drug brentuximab vedotin before or after your stem cell transplant, or if you received at least 3 kinds of treatment including an autologous stem cell transplant. OPDIVO was approved based on response rate. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

For people with previously treated advanced esophageal squamous cell cancer

OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma, and cannot be removed with surgery, and has come back or spread to other parts of the body after you have received chemotherapy that contains fluoropyrimidine and platinum.

For adults newly diagnosed with malignant pleural mesothelioma (MPM)

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) as a first treatment for adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma which cannot be removed by surgery.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous(IV) use.

For people with gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma (EAC)

OPDIVO® (nivolumab) is a prescription medicine used to treat people with cancer of the stomach (gastric), cancer where the esophagus joins the stomach (gastroesophageal junction), and in people with esophageal adenocarcinoma. OPDIVO may be used in combination with chemotherapy that contains fluoropyrimidine and platinum when your cancer cannot be removed with surgery or has spread to other parts of the body.

It is not known if OPDIVO is safe and effective in children younger than 12 years of age with MSI-H or dMMR metastatic colorectal cancer, or in children younger than 18 years of age for the treatment of any other cancers.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous(IV) use.

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