{"id":5586,"date":"2011-03-07T14:25:01","date_gmt":"2011-03-07T13:25:01","guid":{"rendered":"http:\/\/www.ilmelanoma.com\/"},"modified":"2026-10-17T11:22:47","modified_gmt":"2026-10-17T10:22:47","slug":"melanomas-medical-therapy","status":"publish","type":"page","link":"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/","title":{"rendered":"Medical treatment of melanoma"},"content":{"rendered":"<div class=\"im26-diagnosis-guide\">\n<aside class=\"im26-dg-related\"><strong>How to read this guide<\/strong><\/p>\n<p>Educational information based on the cited sources, not an individual prescription. Editorial revision is not equivalent to specialist clinical validation. Decisions and treatments must be agreed with the treating team; benefits, risks and availability depend on the case.<\/p>\n<\/aside>\n<nav class=\"im26-dg-toc\" aria-label=\"On this page\"><strong>On this page<\/strong><\/p>\n<ol>\n<li><a href=\"#med-orientamento\">Where treatment decisions begin<\/a><\/li>\n<li><a href=\"#med-contesti\">Adjuvant, neoadjuvant and advanced-disease treatment<\/a><\/li>\n<li><a href=\"#med-immunoterapia\">Immunotherapy today: checkpoint inhibitors<\/a><\/li>\n<li><a href=\"#med-sicurezza-immuno\">Immune-mediated effects: recognising them promptly<\/a><\/li>\n<li><a href=\"#med-target\">BRAF and MEK targeted treatments<\/a><\/li>\n<li><a href=\"#med-intorno-chirurgia\">Treatment around surgery<\/a><\/li>\n<li><a href=\"#med-chemioterapia\">Chemotherapy and historical immunotherapies<\/a><\/li>\n<li><a href=\"#med-locali\">Regional perfusion and intralesional treatment<\/a><\/li>\n<li><a href=\"#med-radioterapia\">Radiotherapy, brain metastases and symptom control<\/a><\/li>\n<li><a href=\"#med-cellule\">Cellular therapies: distinguishing countries and indications<\/a><\/li>\n<li><a href=\"#med-sperimentali\">Experimental therapies: open questions, not promises<\/a><\/li>\n<li><a href=\"#med-decisioni\">Preparing for consultation and interpreting sources<\/a><\/li>\n<\/ol>\n<\/nav>\n<aside class=\"im26-dg-related\">\n<h2>Explore this pathway<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/drugs-approved-for-melanoma\/\">Approved medicines for melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/braf-v600e\/\">BRAF V600E in melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/ipilimumab-yervoy\/\">Ipilimumab in melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/dabrafenib-and-trametinib\/\">Dabrafenib and trametinib in melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/vemurafenib-2\/\">Vemurafenib in melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/cobimetinib\/\">Cobimetinib in melanoma<\/a><\/li>\n<\/ul>\n<\/aside>\n<section class=\"im26-dg-section\" id=\"med-orientamento\">\n<h2>Where treatment decisions begin<\/h2>\n<p>Medical treatment for melanoma includes approaches acting on the immune system or specific tumour-cell mechanisms, alongside options used in particular circumstances. There is no single best medicine for everyone. Decisions start with histological diagnosis, stage, whether the disease can be removed, relevant mutations and the person\u2019s overall condition.<\/p>\n<p>Cutaneous melanoma must be distinguished from mucosal and ocular forms: their biology and treatment indications are not always interchangeable. Even two people with cutaneous melanoma may have different treatment goals. A BRAF mutation alone establishes neither disease severity nor an obligation to start a particular treatment.<\/p>\n<p>This page is the pathway index: child pages cover <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/drugs-approved-for-melanoma\/\">approved medicines<\/a>, <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/braf-v600e\/\">BRAF V600E<\/a>, <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/ipilimumab-yervoy\/\">ipilimumab<\/a>, <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/vemurafenib-2\/\">vemurafenib<\/a>, <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/cobimetinib\/\">cobimetinib<\/a> and <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/dabrafenib-and-trametinib\/\">dabrafenib with trametinib<\/a>. These explanations are not prescriptions and do not replace multidisciplinary discussion.<\/p>\n<div class=\"im26-dg-gallery\">\n<figure><a href=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-1.png\"><img loading=\"lazy\" src=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-1.png\" width=\"289\" height=\"192\" loading=\"lazy\" decoding=\"async\" alt=\"Medicines: an illustrative archive photograph, not a treatment regimen.\"\/><\/a><figcaption>Medicines: an illustrative archive photograph, not a treatment regimen.<\/figcaption><\/figure>\n<\/div>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39550033\/\">ESMO \u2014 Cutaneous melanoma: Clinical Practice Guideline (2024\/2025)<\/a>; <a href=\"https:\/\/www.cancer.gov\/types\/skin\/hp\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment (PDQ), health professional version<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-contesti\">\n<h2>Adjuvant, neoadjuvant and advanced-disease treatment<\/h2>\n<p>Adjuvant treatment is offered after complete removal in selected melanomas at risk of recurrence. It does not necessarily treat a tumour that remains visible: it aims to lower the risk of disease returning. Expected benefit must be weighed against possible adverse effects in someone who has no detectable disease after surgery.<\/p>\n<p>Neoadjuvant treatment precedes a planned operation in selected settings. In unresectable or metastatic disease, systemic treatment instead aims to control disease, prolong survival and maintain quality of life. These situations must not be confused: the same medicine can have different evidence or authorisations according to stage and treatment setting.<\/p>\n<p>Always ask what the goal is in your case, how the result will be measured and when the strategy will be reassessed. Radiological response, freedom from recurrence and survival are different measures.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.cancer.gov\/types\/skin\/hp\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment (PDQ), health professional version<\/a>; <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39550033\/\">ESMO \u2014 Cutaneous melanoma: Clinical Practice Guideline (2024\/2025)<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-immunoterapia\">\n<h2>Immunotherapy today: checkpoint inhibitors<\/h2>\n<p>Nivolumab and pembrolizumab target the PD-1 checkpoint; ipilimumab targets CTLA-4; relatlimab targets LAG-3 and is available combined with nivolumab. These medicines help release some brakes on the immune response. They are not vaccines or a generic \u201cimmune boost\u201d achievable with supplements.<\/p>\n<p>Anti-PD-1 medicines alone and certain combinations are established options in specific melanoma settings. Nivolumab\u2013ipilimumab can produce durable benefit but increases toxicity risk compared with monotherapy; ten-year CheckMate 067 results document the development of this evidence. No study percentage can predict an individual\u2019s response with certainty.<\/p>\n<p>The European first-line indication for nivolumab\u2013relatlimab requires advanced melanoma and tumour-cell PD-L1 expression below 1%, alongside the age criteria in its label. This requirement should not automatically be extended to every anti-PD-1 medicine or replaced with different US labelling.<\/p>\n<div class=\"im26-dg-gallery\">\n<figure><a href=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2011\/11\/ipilimumab.jpg\"><img loading=\"lazy\" src=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2011\/11\/ipilimumab.jpg\" width=\"264\" height=\"275\" loading=\"lazy\" decoding=\"async\" alt=\"Historical Yervoy packaging: an archive image, not a commercial recommendation.\"\/><\/a><figcaption>Historical Yervoy packaging: an archive image, not a commercial recommendation.<\/figcaption><\/figure>\n<\/div>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/opdivo\">EMA \u2014 Opdivo: indications and product information<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/keytruda\">EMA \u2014 Keytruda: indications and product information<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/yervoy\">EMA \u2014 Yervoy: indications, product information and leaflet<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/opdualag\">EMA \u2014 Opdualag: indications and product information<\/a>; <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39282897\/\">Wolchok et al. \u2014 CheckMate 067, final 10-year outcomes (2024\/2025)<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-sicurezza-immuno\">\n<h2>Immune-mediated effects: recognising them promptly<\/h2>\n<p>Immune activation can affect healthy organs: the bowel, liver, lungs, skin and endocrine glands are possible sites, but not the only ones. Persistent diarrhoea, breathing difficulty, jaundice, marked weakness, unusual headache or important changes should be reported to the team. Some reactions occur after treatment has ended.<\/p>\n<p>Before starting, disclose autoimmune disease, transplants, immunosuppressive treatment and every medicine you take. These are important factors in treatment selection. The centre sets out monitoring, contact arrangements and management of adverse events; treatment interruption or treatment of inflammation may be necessary.<\/p>\n<p>Do not try to compensate for new symptoms with self-treatment or wait until the next infusion. Perceived severity does not always reflect clinical severity, and prompt assessment can prevent complications. Severe or rapidly worsening symptoms require urgent care.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/yervoy\">EMA \u2014 Yervoy: indications, product information and leaflet<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/opdivo\">EMA \u2014 Opdivo: indications and product information<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/keytruda\">EMA \u2014 Keytruda: indications and product information<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-target\">\n<h2>BRAF and MEK targeted treatments<\/h2>\n<p>For melanomas with a BRAF V600 mutation, combinations can block BRAF and MEK, two components of the same signalling pathway. These pairs include dabrafenib\u2013trametinib, vemurafenib\u2013cobimetinib and encorafenib\u2013binimetinib. They are not interchangeable medicines to combine freely: each pair has its own evidence, indications and precautions.<\/p>\n<p>Molecular testing must document a relevant variant. BRAF\/MEK treatment is not a standard choice for melanoma lacking the required mutation. It may shrink tumours rapidly, but resistance can limit benefit duration; immunotherapy remains an option even when BRAF is mutated.<\/p>\n<p>Treatment sequence depends on disease pace, symptoms, involved sites, prior treatment and contraindications. DREAMseq studied the order of combined immunotherapy and dabrafenib\u2013trametinib: its findings support the importance of sequencing without making all clinical situations identical.<\/p>\n<div class=\"im26-dg-gallery\">\n<figure><a href=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2011\/11\/ZELBORAF_logo1.jpg\"><img loading=\"lazy\" src=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2011\/11\/ZELBORAF_logo1.jpg\" width=\"907\" height=\"353\" loading=\"lazy\" decoding=\"async\" alt=\"Historical Zelboraf branding retained in the archive, not a commercial recommendation.\"\/><\/a><figcaption>Historical Zelboraf branding retained in the archive, not a commercial recommendation.<\/figcaption><\/figure>\n<\/div>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/tafinlar\">EMA \u2014 Tafinlar: indications, product information and leaflet<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/cotellic\">EMA \u2014 Cotellic: indications, product information and leaflet<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/braftovi\">EMA \u2014 Braftovi (encorafenib)<\/a>; <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC9839305\/\">DREAMseq \u2014 Randomized treatment-sequence trial (2022\/2023)<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-intorno-chirurgia\">\n<h2>Treatment around surgery<\/h2>\n<p>Adjuvant options include anti-PD-1 treatment in defined stages and dabrafenib\u2013trametinib for selected BRAF V600 stage III melanomas after complete resection. This does not mean every surgically treated melanoma needs medicines: recurrence risk, absolute benefit, comorbidities and preferences should be discussed before deciding.<\/p>\n<p>For some resectable, macroscopic stage III melanomas, neoadjuvant nivolumab\u2013ipilimumab is supported by NADINA. In Italy, AIFA established a specific pathway under Law 648\/1996 in November 2025, with eligibility criteria and subsequent treatment linked to pathological response. This is not a general authorisation for every stage or for omitting surgery.<\/p>\n<p>The centre checks applicable requirements and coordinates treatment, surgery and assessment of the surgical specimen. The possibility of preoperative treatment should not lead patients to delay an indicated operation independently.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/opdivo\">EMA \u2014 Opdivo: indications and product information<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/keytruda\">EMA \u2014 Keytruda: indications and product information<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/tafinlar\">EMA \u2014 Tafinlar: indications, product information and leaflet<\/a>; <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/38828984\/\">Blank et al. \u2014 NADINA, phase 3, NEJM (2024)<\/a>; <a href=\"https:\/\/www.aifa.gov.it\/documents\/20142\/3188844\/Allegato1_Nivolumab_Ipilimumab.pdf\">AIFA \u2014 Nivolumab + ipilimumab, neoadjuvant treatment, Law 648\/1996 (17 November 2025)<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-chemioterapia\">\n<h2>Chemotherapy and historical immunotherapies<\/h2>\n<p>Dacarbazine, temozolomide and other cytotoxic drugs belong to the history of melanoma treatment and to selected contemporary settings. Dacarbazine should no longer be described as the only approved drug for <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/common-types-of-melanoma\/metastatic-melanoma\/\">metastatic melanoma<\/a>, nor should chemotherapy automatically precede appropriate modern options.<\/p>\n<p>Fotemustine, platinum drugs, taxanes and older combinations with vinblastine or tamoxifen are not a list of equivalent treatments to choose from. A drug\u2019s ability to cross the blood\u2013brain barrier does not, by itself, demonstrate strong clinical efficacy against brain metastases. Clinical benefit and pharmacological properties are different concepts.<\/p>\n<p>Interferon, high-dose interleukin-2 and biochemotherapy have had historical roles. BCG, Corynebacterium parvum and levamisole should not be presented as current systemic standards. Toxicity from older strategies can be substantial: a treatment being familiar for many years does not automatically make it safer.<\/p>\n<p>Administration may be oral or intravenous depending on the medicine and protocol. Cytotoxic effects can include reduced blood-cell counts, fatigue, gastrointestinal problems, oral mucosal lesions, hair loss and fertility effects; frequency and severity vary. The plan should include blood tests and instructions for fever or other symptoms without treating every chemotherapy regimen as equivalent.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.cancer.gov\/types\/skin\/hp\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment (PDQ), health professional version<\/a>; <a href=\"https:\/\/www.nice.org.uk\/guidance\/ng14\/chapter\/Recommendations\">NICE NG14 \u2014 Melanoma: assessment and management<\/a>; <a href=\"https:\/\/www.cancer.gov\/types\/skin\/patient\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment, patient version<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-locali\">\n<h2>Regional perfusion and intralesional treatment<\/h2>\n<p>For in-transit metastases confined to a limb, some centres consider isolated perfusion or infusion and other local procedures. The aim is to concentrate treatment in one region, but this does not mean absolute absence of systemic exposure or risk. Pain, swelling and tissue injury can be important; these procedures require careful selection and specialist expertise.<\/p>\n<p>OncoVEX was the development name of the oncolytic virus talimogene laherparepvec, now known as T-VEC\/Imlygic. It should no longer be described solely as a new phase III trial. Its European indication covers specific unresectable disease with skin, subcutaneous or nodal spread and no bone, brain, lung or other visceral disease.<\/p>\n<p>As a modified virus injected into lesions, it requires specific precautions and is not a preventive vaccine. Local effects do not guarantee control of all metastases; availability and suitability must be checked with the centre.<\/p>\n<p>In isolated perfusion at an experienced centre, the limb circulation is temporarily separated from the general circulation and connected to an extracorporeal circuit; warming and medicines may be used according to the protocol. The procedure involves anaesthesia and monitoring for systemic leakage. Isolated infusion is a different technique: the terminology and risks should be explained before consent.<\/p>\n<div class=\"im26-dg-gallery\">\n<figure><a href=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-2.gif\"><img loading=\"lazy\" src=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-2.gif\" width=\"500\" height=\"500\" loading=\"lazy\" decoding=\"async\" alt=\"Historical isolated-limb perfusion diagram; a specialist procedure for selected cases.\"\/><\/a><figcaption>Historical isolated-limb perfusion diagram; a specialist procedure for selected cases.<\/figcaption><\/figure>\n<figure><a href=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-3-oncovex.jpg\"><img loading=\"lazy\" src=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-3-oncovex.jpg\" width=\"800\" height=\"480\" loading=\"lazy\" decoding=\"async\" alt=\"Historical OncoVEX diagram: the subsequent T-VEC has selected indications described in the text.\"\/><\/a><figcaption>Historical OncoVEX diagram: the subsequent T-VEC has selected indications described in the text.<\/figcaption><\/figure>\n<\/div>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.nice.org.uk\/guidance\/ng14\/chapter\/Recommendations\">NICE NG14 \u2014 Melanoma: assessment and management<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/imlygic\">EMA \u2014 Imlygic (talimogene laherparepvec)<\/a>; <a href=\"https:\/\/www.cancer.gov\/types\/skin\/patient\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment, patient version<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-radioterapia\">\n<h2>Radiotherapy, brain metastases and symptom control<\/h2>\n<p>Radiotherapy is a local treatment rather than a medicine, but it may be integrated with systemic care. It has roles in controlling selected sites and relieving symptoms. Brain metastasis management may involve neurosurgery, stereotactic radiosurgery and systemic therapy according to lesion number, size, symptoms and the overall situation.<\/p>\n<p>Gamma Knife and CyberKnife identify technologies: the machine\u2019s name does not establish superiority or equivalence to another approach. Stereotactic radiosurgery should not simply be equated with whole-brain irradiation. Painful bone metastases or lesions at risk of fracture also require clinical and, where necessary, orthopaedic assessment.<\/p>\n<p>Imiquimod may have specialist off-label use for selected in-situ <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/common-types-of-melanoma\/lentigo-maligna-melanoma\/\">lentigo maligna<\/a>; it is not a standard systemic treatment for metastatic melanoma. The <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-surgical-therapy\/\">surgical treatment<\/a> pathway explains this context.<\/p>\n<div class=\"im26-dg-gallery\">\n<figure><a href=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-radioterapia.jpg\"><img loading=\"lazy\" src=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-radioterapia.jpg\" width=\"405\" height=\"303\" loading=\"lazy\" decoding=\"async\" alt=\"Radiotherapy equipment: an archive photograph, not an indication of a technique for an individual patient.\"\/><\/a><figcaption>Radiotherapy equipment: an archive photograph, not an indication of a technique for an individual patient.<\/figcaption><\/figure>\n<\/div>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39550033\/\">ESMO \u2014 Cutaneous melanoma: Clinical Practice Guideline (2024\/2025)<\/a>; <a href=\"https:\/\/www.nice.org.uk\/guidance\/ng14\/chapter\/Recommendations\">NICE NG14 \u2014 Melanoma: assessment and management<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-cellule\">\n<h2>Cellular therapies: distinguishing countries and indications<\/h2>\n<p>Adoptive cell transfer uses immune cells prepared for treatment. TIL products use lymphocytes obtained from the tumour, expanded and reinfused through a complex pathway that may include preparative chemotherapy and interleukin-2. This is not a simple transfusion and can require highly specialised care.<\/p>\n<p>Lifileucel\/Amtagvi received accelerated FDA approval in the United States in 2024 for a specific previously treated advanced-melanoma population. The European application was withdrawn in July 2025, as documented by EMA. It should therefore not be presented as routinely authorised in the European Union on the basis of the US decision.<\/p>\n<p>Research on TILs, engineered cells and modified T-cell receptors continues. Tumour regressions in a small study do not establish a general success rate: protocol, selection, toxicity and duration of control are essential to interpretation.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/approved-blood-products\/amtagvi\">FDA \u2014 Amtagvi (lifileucel), accelerated approval<\/a>; <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/amtagvi\">EMA \u2014 Amtagvi: withdrawal of marketing-authorisation application (2025)<\/a>; <a href=\"https:\/\/www.cancer.gov\/types\/skin\/hp\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment (PDQ), health professional version<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-sperimentali\">\n<h2>Experimental therapies: open questions, not promises<\/h2>\n<p>Research directions include personalised therapeutic vaccines, new immune-treatment combinations and approaches to overcome resistance. INTerpath-001 (NCT05933577) studies intismeran autogene\/V940 with pembrolizumab after surgery for high-risk melanoma. This is treatment for people who have had cancer, not vaccination to prevent melanoma in the general population.<\/p>\n<p>Morpheus-Melanoma explored new neoadjuvant combinations in phase Ib\/II. Other programmes investigate targets such as CD137 or CD40: a target\u2019s name does not mean an available standard already exists. Each combination must be assessed individually; an approved medicine can be experimental when used in a different regimen or setting.<\/p>\n<p>A trial may provide research access but does not guarantee personal benefit. It requires a registered protocol, eligibility criteria, ethical review and informed consent. Check availability and alternatives with the oncologist without independently stopping or delaying treatment. \u201cActive\u201d in a registry does not necessarily mean recruitment is open at your centre.<\/p>\n<div class=\"im26-dg-gallery\">\n<figure><a href=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-vaccini.jpg\"><img loading=\"lazy\" src=\"https:\/\/www.ilmelanoma.com\/wp-content\/uploads\/2009\/10\/terapia-medica-vaccini.jpg\" width=\"343\" height=\"259\" loading=\"lazy\" decoding=\"async\" alt=\"Vaccines: an illustrative image, not evidence of efficacy or availability of a melanoma vaccine.\"\/><\/a><figcaption>Vaccines: an illustrative image, not evidence of efficacy or availability of a melanoma vaccine.<\/figcaption><\/figure>\n<\/div>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05933577\">ClinicalTrials.gov \u2014 INTerpath-001, NCT05933577, phase 3<\/a>; <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40993242\/\">Morpheus-Melanoma \u2014 Randomized phase 1b\/2 study (2025)<\/a>; <a href=\"https:\/\/www.cancer.gov\/research\/participate\/how\/treatment-trials\">National Cancer Institute \u2014 Participate in Cancer Treatment Trials<\/a>; <a href=\"https:\/\/www.cancer.gov\/types\/skin\/hp\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment (PDQ), health professional version<\/a>; <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41775435\/\">Phase I\/II melanoma vaccine with CD40 agonist \u2014 JITC (2026)<\/a>; <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41888981\/\">LOAd703 \u2014 Engineered CD40L\/4-1BBL approach in resistant melanoma (2026)<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-decisioni\">\n<h2>Preparing for consultation and interpreting sources<\/h2>\n<p>Bring reports, a complete medication list and written questions: what goal, expected benefit, alternatives, monitoring and contact arrangements apply? Also clarify the impact on work, fertility, pregnancy, travel and family support. Supportive care and pain control are part of the pathway, not a sign that anticancer care has been abandoned.<\/p>\n<p>A median survival is not a personal deadline; a relative risk reduction is not the same percentage of cures. Reliable comparisons require defined populations and <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/what-to-do-after-melanoma\/\">follow-up<\/a> periods. Historical percentages are therefore dated and linked to their study, while indications refer to guidelines and regulatory documents.<\/p>\n<p>EMA describes European authorisation; AIFA determines Italian access and reimbursement through applicable pathways. The centre always checks the actual situation. The editorial revision date records source checking and does not certify specialist clinical review.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.cancer.gov\/research\/participate\/how\/treatment-trials\">National Cancer Institute \u2014 Participate in Cancer Treatment Trials<\/a>; <a href=\"https:\/\/www.aifa.gov.it\/domanda-rimborsabilita-e-prezzo\">AIFA \u2014 Reimbursement and pricing<\/a>; <a href=\"https:\/\/www.cancer.gov\/types\/skin\/hp\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment (PDQ), health professional version<\/a>.<\/small><\/p>\n<\/section>\n<aside class=\"im26-dg-related\">\n<h2>Continue reading<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/drugs-approved-for-melanoma\/\">Approved medicines for melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/braf-v600e\/\">BRAF V600E in melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/ipilimumab-yervoy\/\">Ipilimumab in melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/vemurafenib-2\/\">Vemurafenib in melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/cobimetinib\/\">Cobimetinib in melanoma<\/a><\/li>\n<li><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/dabrafenib-and-trametinib\/\">Dabrafenib and trametinib in melanoma<\/a><\/li>\n<\/ul>\n<\/aside>\n<section class=\"im26-dg-sources\">\n<h2>Sources and update<\/h2>\n<ul>\n<li><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39550033\/\">ESMO \u2014 Cutaneous melanoma: Clinical Practice Guideline (2024\/2025)<\/a><\/li>\n<li><a href=\"https:\/\/www.cancer.gov\/types\/skin\/hp\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment (PDQ), health professional version<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/opdivo\">EMA \u2014 Opdivo: indications and product information<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/keytruda\">EMA \u2014 Keytruda: indications and product information<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/yervoy\">EMA \u2014 Yervoy: indications, product information and leaflet<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/opdualag\">EMA \u2014 Opdualag: indications and product information<\/a><\/li>\n<li><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39282897\/\">Wolchok et al. \u2014 CheckMate 067, final 10-year outcomes (2024\/2025)<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/tafinlar\">EMA \u2014 Tafinlar: indications, product information and leaflet<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/cotellic\">EMA \u2014 Cotellic: indications, product information and leaflet<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/braftovi\">EMA \u2014 Braftovi (encorafenib)<\/a><\/li>\n<li><a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC9839305\/\">DREAMseq \u2014 Randomized treatment-sequence trial (2022\/2023)<\/a><\/li>\n<li><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/38828984\/\">Blank et al. \u2014 NADINA, phase 3, NEJM (2024)<\/a><\/li>\n<li><a href=\"https:\/\/www.aifa.gov.it\/documents\/20142\/3188844\/Allegato1_Nivolumab_Ipilimumab.pdf\">AIFA \u2014 Nivolumab + ipilimumab, neoadjuvant treatment, Law 648\/1996 (17 November 2025)<\/a><\/li>\n<li><a href=\"https:\/\/www.nice.org.uk\/guidance\/ng14\/chapter\/Recommendations\">NICE NG14 \u2014 Melanoma: assessment and management<\/a><\/li>\n<li><a href=\"https:\/\/www.cancer.gov\/types\/skin\/patient\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment, patient version<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/imlygic\">EMA \u2014 Imlygic (talimogene laherparepvec)<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/approved-blood-products\/amtagvi\">FDA \u2014 Amtagvi (lifileucel), accelerated approval<\/a><\/li>\n<li><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/amtagvi\">EMA \u2014 Amtagvi: withdrawal of marketing-authorisation application (2025)<\/a><\/li>\n<li><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05933577\">ClinicalTrials.gov \u2014 INTerpath-001, NCT05933577, phase 3<\/a><\/li>\n<li><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40993242\/\">Morpheus-Melanoma \u2014 Randomized phase 1b\/2 study (2025)<\/a><\/li>\n<li><a href=\"https:\/\/www.cancer.gov\/research\/participate\/how\/treatment-trials\">National Cancer Institute \u2014 Participate in Cancer Treatment Trials<\/a><\/li>\n<li><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41775435\/\">Phase I\/II melanoma vaccine with CD40 agonist \u2014 JITC (2026)<\/a><\/li>\n<li><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41888981\/\">LOAd703 \u2014 Engineered CD40L\/4-1BBL approach in resistant melanoma (2026)<\/a><\/li>\n<li><a href=\"https:\/\/www.aifa.gov.it\/domanda-rimborsabilita-e-prezzo\">AIFA \u2014 Reimbursement and pricing<\/a><\/li>\n<\/ul>\n<p>Editorial revision and source consultation: 17 October 2026. Study dates distinguish current evidence from historical documents. This date does not certify specialist clinical review.<\/p>\n<\/section>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Immunotherapy, targeted treatments and selected options: understanding aims, evidence, risks and access to care.<\/p>\n","protected":false},"author":13,"featured_media":0,"parent":4144,"menu_order":10,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-5586","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical treatment of melanoma<\/title>\n<meta name=\"description\" content=\"This article will explore recent advances in the medical therapy of melanoma, focusing on innovative treatments such as immunotherapy, targeted therapy, and the combination of different therapeutic strategies.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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