All rights reserved. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). Institute medical management promptly, including specialty consultation as appropriate. Request a free legal case evaluation today. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Imfinzi [package insert]. The site is secure. The drugs stopped his tumor growth for months. Of the 393 patients with uHCC treated with tremelimumab-actl in combination with durvalumab, 50% of patients were 65 years or older and 13% of patients were 75 years or older. The recommended dosage of tremelimumab-actl for the treatment of uHCC in adults is based on body weight as follows: Body weight 30 kg and more: tremelimumab-actl 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab 1,500 mg as a single agent every 4 weeks. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCEs Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Tremelimumab is a cancer treatment drug manufactured by AstraZeneca. The safety and effectiveness of tremelimumab-actl have not been established in pediatric patients. Patients taking the medication can receive medications or therapies to treat each side effect or keep them under control. Interaction highlights: Please see product labeling for drug interaction information. IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. MEDI4736 or MEDI4736 + Tremelimumab in Surgically Resectable Malignant Pleural Mesothelioma, https://www.sciencedirect.com/science/article/abs/pii/S2213260021000436, https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=448620, https://www.astrazeneca.com/media-centre/press-releases/2015/tremelimumab-orphan-drug-designation-us-fda-malignant-mesothelioma-treatment-15042015.html, https://www.astrazeneca.com/our-science/pipeline.html, https://web.archive.org/web/20150905112429/https://www.pfizer.com/system/files/products/material_safety_data/PZ00158.pdf, https://clinicaltrials.gov/ct2/show/NCT02592551, https://www.clinicaltrials.gov/ct2/show/NCT02588131, https://clinicaltrials.gov/ct2/show/study/NCT01843374, https://www.clinicaltrials.gov/ct2/show/NCT03075527, Immune checkpoint blocker, monoclonal antibody, Ticilimumab, anti-CTLA 4 monoclonal antibody-Pfizer, CP-675, CP-675206, Skin reaction, skin rash, itching sensation, diarrhea, nausea, fatigue and immune-mediated disorders. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. Asbestos.com. The purpose of tremelimumab is to blog receptors on immune cells that Tremelimumab-actl is indicated, in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). (n.d.). CONTRAINDICATIONS . Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Thank you for your feedback. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Drug class: anti-CTLA-4 monoclonal antibodies. The tremelimumab antibody activates an immune cell known as cytotoxic T lymphocytes (CTLs), or killer T cells. Get help paying for treatment, lost wages & more. Each page includes all sources for full transparency. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not. Last modified February 24, 2023. https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. Receptors interpret and respond to signals from multiple factors, such as cancerous cells. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. While immune-mediated adverse reactions usually manifest during treatment, immune-mediated adverse reactions can also manifest after discontinuation of tremelimumab-actl and/or durvalumab. Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. 2023 AstraZeneca. Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Tremelimumab succeeds by activating immune cells, called cytotoxic T lymphocytes (CTLs), or killer T cells, which kill cancer cells. The study concluded is estimated to be completed in late 2019. You may report side effects related to AstraZeneca products by clicking here. For platinum-based chemotherapy or pemetrexed, refer to Prescribing Information for administration information Observe for 60 minutes following completion of infusion; then administer durvalumab as a separate IV infusion over 60 minutes on same day Combination with durvalumab: Infuse tremelimumab, followed by durvalumab on same day of dosing Prior results do not predict a similar outcome. Refer to the prescribing information for agents administered in combination with tremelimumab-actl for breastfeeding recommendations, as appropriate. "My family has only the highest compliment for the assistance and support that we received from The Mesothelioma Center. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to tremelimumab-actl are unknown. These immune cells kill cancer cells. This website information is proprietary, protected, and not a substitute for professional medical advice, diagnosis or treatment. 2. 322 0 obj
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Clinical Trials Using Tremelimumab. Based on findings from animal studies and its mechanism of action, tremelimumab-actl can cause fetal harm when administered to a pregnant woman. For information on the COVID-19 pandemic, see the following resources: Follow the Oncology Center of Excellence on Twitter@FDAOncology. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Events resolved in 6 of the 9 patients. Orphan designation does not guarantee the drug is safe or effective and does not mean the FDA will approve it. See USPI Dosing and Administration for specific details. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions. Dosage summary: Administer tremelimumab-actl as an intravenous infusion over 60 minutes after dilution. et al. Withhold or permanently discontinue tremelimumab-actl in combination with durvalumab based on the severity. Medically reviewed by Drugs.com on Nov 29, 2022. While smaller trials have shown success, more research on the drug is needed to treat future patients. Maternal IgG is known to be present in human milk. Events resolved in 12 of the 29 patients and resulted in permanent discontinuation in 9 patients. IMFINZI and IMJUDO are registered trademarks and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions. The results led the researchers to conclude that the treatment combination was associated with long-term survival. Other immune-mediated adverse reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of aseptic meningitis, immune thrombocytopenia, myocarditis, hemolytic anemia, myositis, uveitis, keratitis, and myasthenia gravis. For more information, visit our sponsors page. Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica. There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl). Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions. Monoclonal antibody drugs for cancer: How they work. Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey. Most common adverse reactions ( 20%) of patients with uHCC receiving tremelimumab-actl are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. However, as required by the new California Consumer Privacy Act (CCPA), you may record your preference to view or remove your personal information by completing the form below. In 2021, a clinical research study followed up with mesothelioma patients four years after they received tremelimumab and durvalumab. This is a staff of compassionate and knowledgeable individuals who respect what your family is experiencing and who go the extra mile to make an unfortunate diagnosis less stressful. Retrieved from, National Cancer Institute. Oncologist and Hematologist & Contributing Writer. MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Severe and Fatal Immune-Mediated Adverse Reactions Your web browser is no longer supported by Microsoft. ORR was 20.1% (95% CI: 16.3, 24.4) in the tremelimumab plus durvalumab arm and 5.1% (95% CI: 3.2, 7.8) for those treated with sorafenib. Systemic corticosteroids were required in all 9 patients and of these, 7 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). This website and its content may be deemed attorney advertising. This is a randomized, open-label, multi-center, global, Phase II study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy and tremelimumab monotherapy in the treatment of patients with recurrent or metastatic PD-L1-negative squamous cell carcinoma of the head and neck