{"entity":{"id":"mechlorethamine","kind":"drug","name":"Mechlorethamine (chlormethine)","aka":["Nitrogen mustard","Chlormethine","Ledaga"],"tldr":"Mechlorethamine, or nitrogen mustard, was the first chemotherapy ever used, in 1940s Hodgkin lymphoma. Today its main use is as a skin gel (Valchlor in the US, Ledaga in Europe) for early cutaneous T-cell lymphoma.","summary":"Intravenous mechlorethamine (Mustargen, approved 1949) was the M in MOPP, the first curative combination chemotherapy for Hodgkin disease, and was labelled for Hodgkin and non-Hodgkin lymphomas, leukaemias, mycosis fungoides, bronchogenic carcinoma and malignant effusions; the intravenous product has been discontinued in the US. The 0.016% gel (Valchlor) was approved in August 2013 for stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma after prior skin-directed therapy, on a randomised observer-blinded trial (Study 201) against a compounded ointment; the EU authorised Ledaga in 2017 for the same indication. Contact dermatitis is the main adverse effect of the gel; the intravenous form was a potent vesicant and emetogen.","status":"approved","asOf":"2026-09-24","wikipedia":"https://en.wikipedia.org/wiki/Chlormethine","links":[{"label":"Study 201 (JAMA Dermatol 2013)","url":"https://doi.org/10.1001/2013.jamadermatol.541"},{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/mechlorethaminehydrochloride"},{"label":"EPAR (Ledaga)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ledaga"}],"tags":["nci-list","historic"],"related":[],"cancers":["hodgkin-lymphoma","cutaneous-t-cell-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":["helsinn","recordati"],"institutions":[],"pathways":[],"terms":[],"trials":["study-201"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Mustargen (historic) / Valchlor gel","modality":"Alkylating agent (nitrogen mustard); intravenous and topical gel","mechanism":"Bifunctional alkylating agent that forms interstrand DNA cross-links; the topical gel acts locally on malignant T cells in the skin.","approvals":[{"region":"US","year":1949,"indication":"Hodgkin disease and other lymphomas, leukaemias, mycosis fungoides (intravenous; discontinued)"},{"region":"US","year":2013,"indication":"Topical treatment of stage IA and IB mycosis fungoides-type CTCL after skin-directed therapy (Valchlor)"},{"region":"EU","year":2017,"indication":"Topical treatment of mycosis fungoides-type CTCL (Ledaga)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/mechlorethamine/","neighbours":{"cancer":[{"id":"cutaneous-t-cell-lymphoma","kind":"cancer","name":"Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome)","route":"/cancers/cutaneous-t-cell-lymphoma/"},{"id":"hodgkin-lymphoma","kind":"cancer","name":"Hodgkin lymphoma","route":"/cancers/hodgkin-lymphoma/"},{"id":"mycosis-fungoides","kind":"cancer","name":"Mycosis fungoides","route":"/cancers/mycosis-fungoides/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"company":[{"id":"helsinn","kind":"company","name":"Helsinn","route":"/companies/helsinn/"},{"id":"recordati","kind":"company","name":"Recordati","route":"/companies/recordati/"}],"trial":[{"id":"study-201","kind":"trial","name":"Study 201","route":"/trials/study-201/"}],"term":[{"id":"rejuv-second-alkylating-agents-and-myeloid-neoplasms","kind":"term","name":"Alkylating agents and therapy-related myeloid neoplasms","route":"/terms/rejuv-second-alkylating-agents-and-myeloid-neoplasms/"},{"id":"lymphoma-tx-skin-directed-therapy","kind":"term","name":"Skin-directed therapy in mycosis fungoides: creams, light and small radiotherapy fields","route":"/terms/lymphoma-tx-skin-directed-therapy/"},{"id":"lymphoma-tx-uk-access","kind":"term","name":"What the NHS in England funds for lymphoma, appraisal by appraisal","route":"/terms/lymphoma-tx-uk-access/"}],"paper":[{"id":"paper-study-201-jama-dermatol-2013","kind":"paper","name":"Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides","route":"/key-papers/paper-study-201-jama-dermatol-2013/"}]}}