On March 18, 2025 Medison Pharma , a global company focused on accelerating access to highly innovative therapies in international markets, and Immunocore Holdings plc (NASDAQ: IMCR), a commercial-stage biotechnology company pioneering the delivery of transformative immunomodulatory medicines to radically improve patient outcomes for cancer, infectious diseases and autoimmune diseases, reported that KIMMTRAK (tebentafuspe) has received approval for health registration by the National Health Surveillance Agency (ANVISA), under the regulatory approval pathway for rare diseases (Press release, Medison Pharma, MAR 18, 2025, View Source [SID1234651240]).
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Tebentafuspe is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mum). This is the first therapy approved by ANVISA for metastatic uveal melanoma in Brazil [1],[2] .
Uveal melanoma is a rare and aggressive eye cancer with limited treatment options available at an advanced stage. Once metastasized, it carries a poor prognosis, and survival rates have remained largely unchanged for decades [ 3] . Developed by Immunocore,
tebentafuspe is an innovative immune mobilization monoclonal T-cell receptor therapy against cancer (ImmTAC) [ 4] designed to engage the body’s immune system to specifically target and destroy uveal melanoma cells.
As part of their long-standing global partnership, Medison and Immunocore are collaborating to bring this therapy to Latin America and beyond the U.S., Japan and Western Europe. Brazil has become the first country in the region to obtain approval for the drug, which offers a new treatment option for patients living with this disease [ 5] .
Mark Moyer , Senior Vice President of Regulatory Sciences at Immunocore said: "Following the approval of the registration, HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in Brazil can now access tebentafuspe. With approvals in 39 countries, this underscores Immunocore’s firm commitment to providing our medicines to patients who can benefit from them around the world."
The approval of tebentafuspe in Brazil underscores Medison’s commitment to expanding access to innovative oncology treatments in Latin America. Victor Papamoniodis , Chief Commercial Officer of Medison Pharma, said: "We are proud of our global partnership with Immunocore that allows us to bring this treatment to Brazilian patients who have not had access to an approved therapy until now. Medison is dedicated to providing the most advanced therapies for rare and serious diseases to patients around the world."
Edson Paixão, General Manager of Medison Pharma in Brazil, Andean Region, Central America and the Caribbean , reinforced: "Medison remains committed to accelerating access to highly innovative therapies for Brazilian patients. The approval of tebentafuspe is an important milestone, and we are proud to make this therapy available to patients who can benefit from it."
About KIMMTRAK (tebentafuspe)
Solution for dilution for infusion with 100 micrograms/0.5 mL in a pack containing 1 vial of 0.5 mL.
INTRAVENOUS USE
ADULT USE
WARNING: Cytokine Release Syndrome (CRS), which can be serious or life-threatening, has occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours after the first three infusions and then as clinically indicated.
Indications: As monotherapy for the treatment of adult patients with unresectable or metastatic uveal melanoma positive for human leukocyte antigen (HLA) A*02:01.
Patients treated with KIMMTRAK must have an HLA-A*02:01 genotype determined by any validated HLA genotyping assay.
Contraindications: Hypersensitivity to the active substance or to any of the excipients listed.
Warnings and Precautions: Most patients experienced CRS following tebentafuspe infusions. The diagnosis of CRS was most frequently based on pyrexia followed by hypotension and infrequently on hypoxia. Other symptoms commonly observed with CRS included chills, nausea, vomiting, fatigue, and headache. In most cases, CRS began on the day of infusion, with a median time to resolution of 2 days. Pyrexia was observed in nearly all cases of CRS, and in these patients, an increase in body temperature typically occurred within the first 8 hours after tebentafuspe infusion. CRS rarely (1.2%) led to discontinuation of treatment. Patients should be monitored for signs and symptoms of CRS for at least 16 hours after the first three tebentafuspe infusions in a hospital setting with immediate access to resuscitation drugs and equipment to manage CRS. If CRS is observed, immediate supportive care, including antipyretics, intravenous fluids, tocilizumab, or corticosteroids, should be initiated to prevent worsening of the syndrome or potential fatality, and monitoring should continue until resolution. With subsequent doses, patients should be closely monitored after treatment for early identification of signs and symptoms of CRS. Patients with comorbidities, including cardiovascular disorders, may be at increased risk of sequelae associated with CRS. Tebentafuspe treatment has not been studied in patients with clinically significant cardiac disease. Depending on the persistence and severity of CRS, tebentafuspe treatment should be withheld or discontinued. Acute skin reactions with infusion have been reported, including rash, pruritus, erythema, and skin edema. Cardiac events, such as tachycardia and sinus arrhythmia, have been observed in patients on treatment. Cases of QT prolongation have been reported following treatment with tebentafuspe. An electrocardiogram (ECG) should be performed on all patients before and after treatment, during the first 3 weeks and thereafter as clinically indicated. This medicine may potentiate QT interval prolongation, which increases the risk of serious ventricular arrhythmias such as "torsades de pointes", which is potentially fatal (sudden death). This medicine may cause hepatotoxicity. Therefore, it requires careful use, under strict medical supervision and accompanied by periodic controls of liver function, at the physician’s discretion.
Pregnancy and lactation: Women of childbearing potential must use effective contraception during treatment and for at least 1 week after the last dose of treatment. The drug is not recommended during pregnancy and in women of childbearing potential who are not using contraception. Pregnancy in women of childbearing potential should be ascertained before starting treatment. There is insufficient information on the excretion of tebentafuspe/metabolites in human milk. A risk to the newborn/infant cannot be excluded. Breast-feeding should be discontinued during treatment with tebentafuspe.
Drug, food and alcohol interactions: No formal interaction studies have been performed with tebentafuspe. Initiation of tebentafuspe therapy causes a transient release of cytokines that may suppress CYP450 enzymes . The highest risk of drug-drug interactions occurs within the first 24 hours of the first three doses of tebentafuspe in patients who are receiving concomitant CYP450 substrates , particularly those with a narrow therapeutic index. These patients should be monitored for toxicity (e.g., warfarin) or drug concentrations (e.g., cyclosporine). The dose of concomitant medications should be adjusted as necessary.
Dosage: Hospitalization is recommended for at least the first three infusions. The recommended dose is 20 micrograms on Day 1, 30 micrograms on Day 8, 68 micrograms on Day 15, and 68 micrograms once weekly thereafter. Treatment should continue as long as the patient derives clinical benefit and in the absence of unacceptable toxicities. To minimize the risk of hypotension associated with CRS, intravenous fluids should be administered prior to initiating the infusion, based on clinical assessment and the patient’s volume status. Tebentafuspe should be withheld or discontinued to manage adverse reactions. The recommended infusion period is 15 to 20 minutes.
Adverse reactions and laboratory test abnormalities: The most common adverse reactions in patients treated with tebentafusp were CRS (88%), rash (85%), pyrexia (79%), pruritus (72%), fatigue (66%), nausea (56%), chills (55%), abdominal pain (49%), edema (49%), hypo/hyperpigmentation (48%), hypotension (43%), dry skin (35%), headache (32%), and vomiting (34%). Adverse reactions led to permanent discontinuation in 4% of treated patients. The most common adverse reaction resulting in discontinuation of tebentafusp was CRS. Adverse reactions resulting in at least one dose interruption occurred in 26% of treated patients (weekly dosing) and resulted in a median of one missed dose. Adverse reactions requiring dose interruption in ≥2% of patients included fatigue (3%; Grade 1-3), pyrexia (2.7%; Grade 1-3), alanine aminotransferase increased (2.4%; Grade 1-4), aspartate aminotransferase increased (2.4%; Grade 1-3), abdominal pain (2.1%; Grade 1-3), and lipase increased (2.1%; Grade 1-3). Adverse reactions leading to dose modification in ≥1% of patients were CRS (1.9%; Grade 1-3) and hypotension (1.1%; Grade 2-4). Very common adverse reactions were: CRS, decreased appetite, hypomagnesemia, hyponatremia, hypocalcemia, hypokalemia, insomnia, headache, dizziness, paresthesia, tachycardia, hypotension, flushing, hypertension, cough, dyspnea, nausea, vomiting, diarrhea, abdominal pain, constipation, dyspepsia, rash, pruritus, dry skin, hypo/hyperpigmentation, erythema, arthralgia, back pain, myalgia, pain in extremity, pyrexia, fatigue, chills, edema, influenza-like illness, increased aspartate aminotransferase, increased alanine aminotransferase, increased serum bilirubin, increased lipase, anemia, decreased lymphocyte count, decreased serum phosphate, increased serum creatinine. See other adverse reactions in the full product leaflet.
Registration: 1.9132.0001/ Medison Pharma Brasil Produtos Farmacêuticos LTDA /CNPJ 48.682.588/0001-37/ Rua Nelson Pontes , 125 Bloco 5 e 6. Jardim Margarida. Vargem Grande Paulista/SP/Indústria Brasileira/ KIMMTRAK/SAC: 0800-633-4766. SALE UNDER PRESCRIPTION. USE RESTRICTED TO HEALTHCARE ESTABLISHMENTS. If symptoms persist, a physician should be consulted. Scientific documentation and additional information are available from Customer Service and the service department for prescribers and dispensers of medication. Product information approved by Anvisa is available at View Source