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Pralatrexate was the first drug approved specifically for relapsed peripheral T-cell lymphoma; about a third of patients respond.
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.
Folate analogue with high affinity for the reduced folate carrier (RFC-1) and efficient polyglutamylation, selectively accumulating in tumour cells and inhibiting DHFR.
1.Pralatrexate slips into a pocket on its target.
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.
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.
Sources: NICE search: pralatrexate. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of relapsed or refractory peripheral T-Cell Lymphoma (PTCL)
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 17.0 years later, when the FDA's table was read.
| Region | Year | Indication |
|---|---|---|
| US | 2009 | Relapsed/refractory peripheral T-cell lymphoma |
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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.
Shares Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL, To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL, Acrotech Biopharma, Spectrum Pharmaceuticals.
Shares Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL, What the NHS in England funds for lymphoma, appraisal by appraisal, Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma), Sezary syndrome.
Shares Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma), Sezary syndrome, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).
Shares What the NHS in England funds for lymphoma, appraisal by appraisal, Sezary syndrome, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).
Shares Sezary syndrome, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).
Shares Sezary syndrome, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).
Shares Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma), Sezary syndrome, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).
Shares Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma), Sezary syndrome, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma).