Opdivo + cisplatin + gemcitabine

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Melanoma, NSCLC, Renal cell carcinoma (RCC), Hodgkin lymphoma, urothelial carcinoma, mesothelioma

March 6, 2024 The FDA approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

October 12, 2023 The FDA approved nivolumab (Opdivo) for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.

June 3, 2022 FDA approved Opdivo (nivolumab) in combination with fluoropyrimidine-and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab) as first-line treatments for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.

March 11, 2022 FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy for adult patients with respectable non-small cell lung cancer in the neoadjuvant setting. This represents the first FDA approval for neoadjuvant therapy for early-stage NSCLC.

August 19, 2021 The FDA approved nivolumab (Opdivo) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection.

May 21, 2021 FDA approved nivolumab (Opdivo) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

April 6, 2021 The FDA approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the
initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

January 22, 2021 FDA approved the combination of nivolumab (Opdivo) and cabozantinib (Cabometyx), as first-line treatment for patients with advanced renal cell carcinoma (RCC).

October 2, 2020: The FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug
regimen approved for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma.

June 10, 2020: The FDA approved nivolumab (OPDIVO) for patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

May 26, 2020: The FDA approved the combination of nivolumab (OPDIVO) plus ipilimumab (YERVOY)and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

May 15, 2020: The FDA approved the combination of nivolumab (OPDIVO) plus ipilimumab (YERVOY) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

March 10, 2020 The FDA granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO and YERVOY) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

8/26/018: FDA granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company Inc.) for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy.

4/16/2018 FDA granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.

12/20/2017: FDA approved Opdivo for adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection.
8/1/2017: FDA granted accelerated approval to nivolumab (OPDIVO) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
2/2/2017: FDA approved the nivolumab (Opdivo) injection for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Opdivo received FDA approval December 22, 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression.
March 2015: FDA expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
September 30, 2015:Opdivo received FDA approval for use in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma.
November 24, 2015: FDA approved Opdivo (nivolumab) to treat patients with advanced/metastatic renal cell carcinoma.

May 17, 2016 FDA granted accelerated approval to nivolumab (Opdivo, marketed by Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris).

November 10, 2016 FDA approved nivolumab (OPDIVO), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.

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An alkylating antineoplastic agent. FDA approved uses on bladder, ovarian and testicular cancer; miscellaneous agent.

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FDA approved for breast. ovarian, pancreas, NSC lung
Gemcitabine HCL is given intravesically as treatment for bladder tumors. Code as chemotherapy.

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