OnCo
drugsProductNot mapped hereapproved

Pralatrexate

Pralatrexate was the first drug approved specifically for relapsed peripheral T-cell lymphoma; about a third of patients respond.

PROPEL (2009): 29% response rate in heavily pretreated PTCL; mucositis is the dose-limiting toxicity, mitigated by folate and B12 supplementation. Accelerated approval; also approved in Japan and China.

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Pralatrexate
PubChem
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.
Brand / code
Folotyn
Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Generic pralatrexate is available.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
NHS England
Not routinely funded

Sources: NICE search: pralatrexate. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2009Relapsed/refractory peripheral T-cell lymphoma

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
27 studies5 recruiting21 Phase 26 Phase 3
Search “Pralatrexate” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Pralatrexate
intervention: Pralatrexate
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Pralatrexate" OR ABSTRACT:"Pralatrexate" OR TITLE:"Folotyn" OR ABSTRACT:"Folotyn") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Pralatrexate, not a curated reading list.

Connected

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