{"id":6109,"date":"2011-11-10T18:57:23","date_gmt":"2011-11-10T17:57:23","guid":{"rendered":"http:\/\/www.ilmelanoma.com\/"},"modified":"2026-10-17T11:22:50","modified_gmt":"2026-10-17T10:22:50","slug":"drugs-approved-for-melanoma","status":"publish","type":"page","link":"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/drugs-approved-for-melanoma\/","title":{"rendered":"Approved medicines for 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-significato\">What \u201capproved\u201d means<\/a><\/li>\n<li><a href=\"#med-immunoterapia\">Established immunotherapies with different indications<\/a><\/li>\n<li><a href=\"#med-target\">Targeted treatments require the relevant target<\/a><\/li>\n<li><a href=\"#med-selezionati\">Selected options and Italian access pathways<\/a><\/li>\n<li><a href=\"#med-sperimentali\">Overseas approvals and experimental treatments<\/a><\/li>\n<\/ol>\n<\/nav>\n<section class=\"im26-dg-section\" id=\"med-significato\">\n<h2>What \u201capproved\u201d means<\/h2>\n<p>A medicine is not approved generically \u201cagainst melanoma\u201d: authorisation concerns an indication, a population and sometimes a specific combination. Stage, mutation, previous treatment and age may define its use. European authorisation and reimbursement by Italy\u2019s national health service are separate steps; the treating centre must check the applicable AIFA conditions.<\/p>\n<p>This page provides relevant examples for cutaneous melanoma, not a complete catalogue of every cancer indication. Its earlier version mainly listed US authorisations and historical brands: that picture did not adequately represent current choices in Italy. A brand identifies a product, not a treatment that is necessarily better than the alternatives.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <a href=\"https:\/\/www.aifa.gov.it\/domanda-rimborsabilita-e-prezzo\">AIFA \u2014 Reimbursement and pricing<\/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>Established immunotherapies with different indications<\/h2>\n<p>Pembrolizumab and nivolumab are anti-PD-1 medicines used in defined advanced-disease and adjuvant settings. Not every stage requires medication after surgery. Assessment considers recurrence risk, expected benefit and potential immune toxicities, including persistent effects.<\/p>\n<p><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/ipilimumab-yervoy\/\">Ipilimumab<\/a> targets CTLA-4 and may be used alone or with nivolumab according to the indication and clinical assessment. The combination is not simply the sum of two monotherapies and needs careful toxicity management. Nivolumab with relatlimab, marketed as Opdualag, has a European Union first-line indication in advanced melanoma with tumour PD-L1 expression below 1%, in adults and adolescents aged 12 or older. This European restriction must not be omitted.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <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\/opdivo\">EMA \u2014 Opdivo: 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:\/\/www.aifa.gov.it\/documents\/20142\/961234\/Determina_466-2024_Opdualag.pdf\">AIFA \u2014 Opdualag: reimbursement determination 466\/2024<\/a>.<\/small><\/p>\n<\/section>\n<section class=\"im26-dg-section\" id=\"med-target\">\n<h2>Targeted treatments require the relevant target<\/h2>\n<p>For melanoma with a BRAF V600 mutation, BRAF\/MEK combinations include dabrafenib\u2013trametinib, <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/vemurafenib-2\/\">vemurafenib<\/a>\u2013<a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/cobimetinib\/\">cobimetinib<\/a> and encorafenib\u2013binimetinib for advanced disease under their respective indications. Their components cannot be freely exchanged. Mutation positivity must be established by a validated test on tumour material.<\/p>\n<p><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/dabrafenib-and-trametinib\/\">Dabrafenib with trametinib<\/a> also has an adjuvant indication in completely resected BRAF V600 stage III melanoma. This does not automatically extend to the other combinations. The variant report and clinical setting require specialist interpretation; having <a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/braf-v600e\/\">BRAF V600E<\/a> does not necessarily mean targeted therapy should be preferred over immunotherapy.<\/p>\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\/mekinist\">EMA \u2014 Mekinist: 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\/zelboraf\">EMA \u2014 Zelboraf: 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:\/\/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-selezionati\">\n<h2>Selected options and Italian access pathways<\/h2>\n<p>Talimogene laherparepvec, or T-VEC\/Imlygic, is an intralesional treatment authorised in Europe for specific unresectable melanomas without visceral metastases: it is not a general solution for all metastatic disease. Chemotherapy now has a narrower role than modern approaches and remains an individualised option in selected circumstances.<\/p>\n<p>A use outside the usual indication may nevertheless have substantial evidence and a specific national access pathway. One example is neoadjuvant nivolumab\u2013ipilimumab under AIFA\u2019s determination of 17 November 2025 through Law 648\/1996. \u201cOff-label\u201d, \u201creimbursed through a dedicated pathway\u201d and \u201cexperimental\u201d are not synonyms: the situation must be stated explicitly.<\/p>\n<p class=\"im26-dg-sources\"><small>Sources for this section: <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\/hp\/melanoma-treatment-pdq\">National Cancer Institute \u2014 Melanoma Treatment (PDQ), health professional version<\/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-sperimentali\">\n<h2>Overseas approvals and experimental treatments<\/h2>\n<p>Lifileucel, a tumour-infiltrating lymphocyte therapy, received accelerated FDA approval in the United States. Amtagvi\u2019s European marketing-authorisation application was withdrawn in 2025: withdrawal of an application must not be confused with withdrawal of an authorisation already granted, nor should this be presented as a routinely available Italian standard.<\/p>\n<p>Personalised neoantigen vaccines and new immunotherapy combinations are being studied. INTerpath-001 records a phase III trial of V940 with pembrolizumab; registry listing does not establish definitive efficacy or access at a particular centre. Participation requires eligibility assessment, informed consent and discussion of alternatives. Do not stop or delay treatment in pursuit of something advertised as \u201cinnovative\u201d.<\/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:\/\/clinicaltrials.gov\/study\/NCT05933577\">ClinicalTrials.gov \u2014 INTerpath-001, NCT05933577, phase 3<\/a>; <a href=\"https:\/\/www.cancer.gov\/research\/participate\/how\/treatment-trials\">National Cancer Institute \u2014 Participate in Cancer Treatment Trials<\/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\/\">Medical treatment of 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<p><a href=\"https:\/\/www.ilmelanoma.com\/en\/melanoma\/melanomas-medical-therapy\/#med-sperimentali\">Experimental treatments: evidence, limitations and trial access<\/a><\/p>\n<\/aside>\n<section class=\"im26-dg-sources\">\n<h2>Sources and update<\/h2>\n<ul>\n<li><a href=\"https:\/\/www.aifa.gov.it\/domanda-rimborsabilita-e-prezzo\">AIFA \u2014 Reimbursement and pricing<\/a><\/li>\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.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\/opdivo\">EMA \u2014 Opdivo: 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:\/\/www.aifa.gov.it\/documents\/20142\/961234\/Determina_466-2024_Opdualag.pdf\">AIFA \u2014 Opdualag: reimbursement determination 466\/2024<\/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\/mekinist\">EMA \u2014 Mekinist: 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\/zelboraf\">EMA \u2014 Zelboraf: 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:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/imlygic\">EMA \u2014 Imlygic (talimogene laherparepvec)<\/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.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.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:\/\/www.cancer.gov\/research\/participate\/how\/treatment-trials\">National Cancer Institute \u2014 Participate in Cancer Treatment Trials<\/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>A map of treatment options: European indications, access in Italy and distinctions from clinical research.<\/p>\n","protected":false},"author":13,"featured_media":0,"parent":5586,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6109","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>Drugs approved for the treatment of melanoma<\/title>\n<meta name=\"description\" content=\"The treatment of melanoma has become increasingly promising ground thanks to the approval of innovative and targeted drugs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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