{"entity":{"id":"pralatrexate","kind":"drug","name":"Pralatrexate","aka":[],"tldr":"Pralatrexate was the first drug approved specifically for relapsed peripheral T-cell lymphoma; about a third of patients respond.","summary":"Pralatrexate is a folate analogue with high affinity for the reduced folate carrier RFC-1 and efficient polyglutamylation, so it accumulates selectively in tumour cells and inhibits dihydrofolate reductase. It is given intravenously to patients with relapsed or refractory peripheral T-cell lymphoma, a group with few options. The single-arm PROPEL study (2009) showed a 29% response rate in heavily pretreated PTCL and supported accelerated US approval in 2009, the first drug licensed specifically for this indication; it is also approved in Japan and China. Mucositis is the dose-limiting toxicity and is mitigated by folate and vitamin B12 supplementation. It offers durable responses in a minority rather than a cure, without randomised survival data. For a newcomer, pralatrexate is a targeted antifolate that helps about a third of relapsed T-cell lymphoma patients.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Pralatrexate","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=pralatrexate"}],"tags":["gap-fill"],"related":[],"cancers":["peripheral-t-cell-lymphoma"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":["acrotech-biopharma","spectrum-pharmaceuticals","mundipharma"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06072131"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Folotyn","modality":"Antifolate (DHFR inhibitor)","mechanism":"Folate analogue with high affinity for the reduced folate carrier (RFC-1) and efficient polyglutamylation, selectively accumulating in tumour cells and inhibiting DHFR.","approvals":[{"region":"US","year":2009,"indication":"Relapsed/refractory peripheral T-cell lymphoma"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2009-09-24","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 17.0 years later, when the FDA's table was read.","indication":"Treatment of relapsed or refractory peripheral T-Cell Lymphoma (PTCL)"}]},"route":"/drugs/pralatrexate/","neighbours":{"cancer":[{"id":"angioimmunoblastic-t-cell-lymphoma","kind":"cancer","name":"Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma)","route":"/cancers/angioimmunoblastic-t-cell-lymphoma/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"},{"id":"sezary-syndrome","kind":"cancer","name":"Sezary syndrome","route":"/cancers/sezary-syndrome/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"company":[{"id":"acrotech-biopharma","kind":"company","name":"Acrotech Biopharma","route":"/companies/acrotech-biopharma/"},{"id":"mundipharma","kind":"company","name":"Mundipharma","route":"/companies/mundipharma/"},{"id":"spectrum-pharmaceuticals","kind":"company","name":"Spectrum Pharmaceuticals","route":"/companies/spectrum-pharmaceuticals/"}],"trial":[{"id":"nct04747236","kind":"trial","name":"Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL","route":"/trials/nct04747236/"},{"id":"nct06072131","kind":"trial","name":"To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL","route":"/trials/nct06072131/"}],"term":[{"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/"}]}}