TREMELIMUMAB
Background and Date of Approval
Tremelimumab is an immunotherapy medicine that enhances the ability of the immune system to identify and eliminate cancer cells. The U.S. Food and Drug Administration approved tremelimumab in October 2022 for treatment of certain liver cancers. Approval was based on the HIMALAYA clinical trial, which demonstrated improved survival outcomes in patients with unresectable liver cancer when tremelimumab was administered with durvalumab. This combination represents a treatment option for patients with liver cancer that cannot be surgically removed.
Uses
Tremelimumab is used in combination with durvalumab for treating: Unresectable hepatocellular carcinoma (HCC) â a type of liver cancer that cannot be treated with surgery. Non-small cell lung cancer (NSCLC) â in certain situations under special approval or clinical studies. It may also be studied for other cancers like melanoma and mesothelioma under clinical trials or specialist advice.
How is it administered?
Tremelimumab is not a tablet or capsule. It is given as an intravenous (IV) infusion in a hospital or clinic by trained healthcare professionals. The dose and how often it is given will depend on the type of cancer and your treatment plan. For liver cancer, a one-time dose of 300 mg is commonly given, followed by regular doses of durvalumab every 4 weeks. Your doctor will decide the exact schedule based on your needs.
Side Effects
Like all medicines, this one can also cause side effects. Some are common and go away on their own, while others may be serious and need medical attention. Common side effects: Tiredness or weakness Diarrhoea or loose stools Skin rash or itching Feeling sick (nausea) Poor appetite Belly pain Joint or muscle pain Serious side effects (need doctorâs attention): Lung inflammation (trouble breathing, dry cough) Liver issues (yellow eyes/skin, dark urine) Hormonal changes (fatigue, weight changes, mood swings) Intestinal inflammation (severe stomach pain, bloody stools) Kidney problems (swelling, change in urination) Report any new or unusual symptoms to your doctor quickly.
Warnings
Not suitable for people with severe autoimmune diseases like lupus or rheumatoid arthritis. Should not be used in pregnancy or while breastfeeding. May cause strong immune reactions affecting different organs. Can interact with other immune-based or steroid medicines. Needs regular blood tests to check liver, kidney, and thyroid function.
Precautions
Before starting treatment, inform your doctor about any past medical problems, especially autoimmune conditions, organ transplants, or chronic infections. Avoid taking any vaccines without your doctorâs advice during the treatment period. Let your doctor know about all the medicines, supplements, or herbal products you are using. During treatment, youâll need regular check-ups and lab tests to catch any problems early. If you notice anything unusual, donât waitâreach out to your healthcare provider right away.
Word of Advice
Pay close attention to how your body responds throughout the treatment. As this medicine stimulates the immune system, it may occasionally cause the immune system to become overactive and affect healthy tissues. Attend all scheduled follow-up appointments and inform your doctor about any side effects, even if they appear mild. Consume light, nutritious meals and stay well hydrated to help maintain your energy levels. Keep a medical card with details of the medicine you are taking and inform other healthcare professionals that you are undergoing immunotherapy, particularly before any emergency treatment or surgery.
References
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approvals-imjudo-tremelimumab-combination-durvalumab-unresectable https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremelimumab-combination-durvalumab-and-platinum-based-chemotherapy-metastatic-non https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761289lbl.pdf
Frequently Asked Questions
What is the drug Tremelimumab used for?
Tremelimumab is used in combination with another medicine called Durvalumab to treat unresectable hepatocellular carcinoma (uHCC), a type of liver cancer that cannot be removed by surgery. It helps the immune system recognise and attack cancer cells more effectively. It is not approved for use on its own.
What is the difference between Ipilimumab and Tremelimumab?
Both Ipilimumab and Tremelimumab belong to a class of drugs called immune checkpoint inhibitors and target the CTLA-4 protein, which helps the immune system fight cancer. The main difference lies in their structure and approval uses: Ipilimumab is FDA-approved for melanoma, lung cancer, and other cancers. Tremelimumab is currently approved only in combination with Durvalumab for liver cancer (uHCC). Additionally, Ipilimumab has been on the market longer and is more widely used.
How much does Tremelimumab cost?
Tremelimumab (Imjudo) is a high-cost cancer immunotherapy. In India, the approximate cost of a single 300 mg vial is around â¹2,00,000 to â¹2,50,000, depending on the hospital and supplier. Since it's given in combination with Durvalumab, the total treatment cost can be significantly higher. Prices may vary based on availability and location.
What is the mechanism of action of Imjudo (Tremelimumab)?
Imjudo (Tremelimumab) works by boosting your immune system to fight cancer. It blocks a protein called CTLA-4, which usually keeps the immune system in check. By blocking this protein, the drug allows immune cells (T-cells) to become more active and attack cancer cells more effectively. Itâs often used with Durvalumab, which works through a different pathway to further support the immune response.