וידאו 02.09.2021

תיאור מקרה: מטופל על פרוטוקול 9LA

ד"ר הדס גנץ-סורוצקי, אונקולוגית בכירה במכון האונקולוגי שיבא-תל השומר

INDICATIONS AND USAGE OPDIVO - 1.1 Unresectable or Metastatic Melanoma OPDIVO, as monotherapy or in combination with ipilimumab, is indicated for the treatment of advanced unresectable or metastatic melanoma in adults. 1.2 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. 1.3 Metastatic Non-Small Cell Lung Cancer · Opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the firstline treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. · OPDIVO is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. 1.4 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. 1.5 Renal Cell Carcinoma · OPDIVO as a single agent is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) in patients 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). 1.6 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. 1.7 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.1.8 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. 1.9 Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer OPDIVO, as a single agent or in combination with ipilimumab, 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. 1.10 Hepatocellular Carcinoma OPDIVO, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated withsorafenib.

INDICATIONS AND USAGE YERVOY- 1.1 Unresectable or Metastatic Melanoma YERVOY (ipilimumab) is indicated for the treatment of advanced (unresectable or metastatic) melanoma. YERVOY (ipilimumab), in combination with nivolumab, is indicated for the treatment of patients with advanced (unresectable or metastatic) melanoma.1.2 Advanced Renal Cell Carcinoma YERVOY, in combination with nivolumab, is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC) 1.3 Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer YERVOY, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years of age 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. 1.4 Metastatic Non-Small Cell Lung Cancer YERVOY, in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. 1.5 Hepatocellular Carcinoma Yervoy, in combination with nivolumab, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated with sorafenib.

Across clinical trials, immune-mediated adverse reactions as Pneumonitis, Colitis, Hepatitis, Endocrinopathies, Nephritis and Renal Dysfunction, Skin Adverse Reactions, Encephalitis and other immune-mediated adverse reactions were observed. • Also observed infusion reactions and Embryo- fetal toxicity. Complications of Allogeneic HSCT after receiving OPDIVO® and increased mortality in patients with Multiple Myeloma when OPDIVO® is added to a Thalidomide Analogue and Dexamethasone.

Dear Physician, for further information please refer to OPDIVO® and YERVOY® Israeli Prescribing Information and Patient leaflets:

https://data.health.gov.il/drugs/index.html#!/medDetails/153 55 34333 00

https://data.health.gov.il/drugs/index.html#!/medDetails/147 62 33522 00

*Reck M. et al. First-line nivolumab + ipilimumab + 2 cycles of chemotherapy versus chemotherapy alone (4 cycles) in patients with non-small cell lung cancer: 2 year update from CheckMate 9LA, Oral presentation at ASCO 2021. Abstract # 9000

בחסות חברת BMS
7356-IL-2100057

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