{"entity":{"id":"pemetrexed","kind":"drug","name":"Pemetrexed","aka":[],"tldr":"Pemetrexed is the chemotherapy that, with a platinum drug, became the first approved treatment for mesothelioma in 2004, and is still the backbone today.","summary":"Pemetrexed is a multitargeted antifolate that inhibits thymidylate synthase, DHFR and GARFT, starving cells of the nucleotides needed for DNA synthesis. In EMPHACIS (2003), cisplatin-pemetrexed gave OS 12.1 versus 9.3 months compared with cisplatin alone, the first randomised survival gain in mesothelioma, and it became the first approved treatment for the disease in 2004. It is now given with pembrolizumab (KEYNOTE-483) or bevacizumab (MAPS), and it was the chemotherapy comparator that nivolumab-ipilimumab beat in CheckMate 743. It is also standard in non-squamous NSCLC, dosed at 500 mg/m2 every 21 days with a platinum for 4 to 6 cycles, then optional maintenance. Folic acid and vitamin B12 supplementation and dexamethasone premedication are required. It remains the chemotherapy backbone in mesothelioma that newer agents are added to rather than replacing.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Pemetrexed","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Pemetrexed"}],"tags":[],"related":[],"cancers":["mesothelioma","nsclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-483","maps","checkmate-743","gefitinib-chemo-tmh","nct06212752","nct04351555","nct06305754","nct06899126","nct04379635","nct05800015","nct06956001","nct06564844","nct06417814","nct06459180","nct06452277","nct05116462","nct03800134","nct06711900","nct06396065","nct04129502","nct06712316","nct06312137","nct05555732","nct05870319","nct06726265","nct06561386","nct02486718","nct05722015","nct07642024","nct06793215","nct06687369","nct06074588","nct05048797","nct06627647","nct04956692","nct05984277","nct03178552","nct07777822","nct07178795","nct06097728","nct07100080","nct05668988","nct06382116","nct05180799","nct06475300","nct03970746","nct06514027","nct06448754","nct06946797","nct05633667","nct07680764","nct06731907","nct05789082","nct05904379","nct03775486","nct06943820","nct05431270","nct05635708","nct06996782","nct06706076","nct06161441","nct05098132","nct06162221","nct04736173","nct07122687","nct07070440","nct07020221","nct04665206","nct05841472","nct06758557","nct05403385","nct04198766","nct05742607","nct04956640","nct07486817","nct05609578","nct06623422","nct05498428","nct06246110","nct06667076","nct06474455","nct07415031","nct06783647","nct06008093","nct04538664","nct05687266","nct06151574","nct07586202","nct04025879","nct05261399","nct06119581","nct07492680","nct07171606","nct05112965","nct06385678","nct06194448","nct07109531","nct05456256","nct06772623","nct03003962","nct06875310","nct05410145","nct04988295","nct06788912","nct05443126","nct06970639","nct06741644","nct04380636"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Alimta (and generics)","modality":"Cytotoxic (antifolate)","mechanism":"Multitargeted antifolate inhibiting thymidylate synthase, DHFR, and GARFT.","approvals":[{"region":"US","year":2004,"indication":"Unresectable pleural mesothelioma with cisplatin"},{"region":"US","year":2008,"indication":"Non-squamous NSCLC first line"}],"mechanismSteps":["Enters cells via the reduced folate carrier","Polyglutamated and retained intracellularly","Inhibits thymidylate synthase, blocking DNA synthesis","Preferential toxicity to rapidly dividing cells; vitamin supplementation protects normal tissue"],"dosing":{"route":"Intravenous","schedule":"500 mg/m² day 1 every 21 days with cisplatin 75 mg/m² or carboplatin AUC 5; 4-6 cycles, then optional maintenance","modifications":"Hold for creatinine clearance <45 mL/min; dexamethasone premedication for rash","monitoring":"Renal function and blood counts; folic acid and B12 supplementation"},"toxicity":[{"event":"Neutropenia (grade 3+)","grade3PlusPct":23},{"event":"Fatigue","anyGradePct":48},{"event":"Nausea","anyGradePct":82},{"event":"Rash","anyGradePct":16}],"access":[],"regulatoryEvents":[{"date":"2004-08-19","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"As a single agent for locally advanced or metastatic NSCLC after prior chemotherapy"},{"date":"2008-09-26","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Non-squamous NSCLC: 1) as initial treatment with cisplatin; 2) as a single agent after prior chemotherapy"},{"date":"2009-07-02","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2004 converted to traditional approval 4.9 years after it was granted.","indication":"As a single agent for locally advanced or metastatic NSCLC after prior chemotherapy"},{"date":"2009-07-02","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2008 converted to traditional approval 0.8 years after it was granted.","indication":"Non-squamous NSCLC: 1) as initial treatment with cisplatin; 2) as a single agent after prior chemotherapy"},{"date":"2018-06-04","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLC"},{"date":"2019-01-30","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2018 converted to traditional approval 0.7 years after it was granted.","indication":"In combination with pembrolizumab and carboplatin for first-line treatment of metastatic non-squamous NSCLC"}]},"route":"/drugs/pemetrexed/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"},{"id":"lung-adenosquamous-carcinoma","kind":"cancer","name":"Adenosquamous carcinoma of the lung","route":"/cancers/lung-adenosquamous-carcinoma/"},{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-nsclc/"},{"id":"braf-v600e-nsclc","kind":"cancer","name":"BRAF V600E-mutant non-small-cell lung cancer","route":"/cancers/braf-v600e-nsclc/"},{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"kras-g12c-nsclc","kind":"cancer","name":"KRAS G12C-mutant non-small-cell lung cancer","route":"/cancers/kras-g12c-nsclc/"},{"id":"large-cell-lung-carcinoma","kind":"cancer","name":"Large cell carcinoma of the lung","route":"/cancers/large-cell-lung-carcinoma/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"mesothelioma","kind":"cancer","name":"Mesothelioma","route":"/cancers/mesothelioma/"},{"id":"met-altered-nsclc","kind":"cancer","name":"MET exon 14 and MET-amplified non-small-cell lung cancer","route":"/cancers/met-altered-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"ntrk-fusion-nsclc","kind":"cancer","name":"NTRK fusion-positive non-small-cell lung cancer","route":"/cancers/ntrk-fusion-nsclc/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"},{"id":"peritoneal-mesothelioma","kind":"cancer","name":"Peritoneal mesothelioma","route":"/cancers/peritoneal-mesothelioma/"},{"id":"pleural-mesothelioma","kind":"cancer","name":"Pleural mesothelioma","route":"/cancers/pleural-mesothelioma/"},{"id":"resectable-nsclc","kind":"cancer","name":"Resectable stage I to III non-small-cell lung cancer","route":"/cancers/resectable-nsclc/"},{"id":"ret-fusion-nsclc","kind":"cancer","name":"RET fusion-positive non-small-cell lung cancer","route":"/cancers/ret-fusion-nsclc/"},{"id":"ros1-positive-nsclc","kind":"cancer","name":"ROS1-positive non-small-cell lung cancer","route":"/cancers/ros1-positive-nsclc/"},{"id":"stage-iii-unresectable-nsclc","kind":"cancer","name":"Unresectable stage III non-small-cell lung cancer","route":"/cancers/stage-iii-unresectable-nsclc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"company":[{"id":"aosaikang-pharmaceutical","kind":"company","name":"Aosaikang Pharmaceutical","route":"/companies/aosaikang-pharmaceutical/"},{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. 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