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Folotyn (Pralatrexate) - Summary



FOLOTYN (pralatrexate injection) contains pralatrexate, which is an antineoplastic folate analog.

FOLOTYN is a folate analog metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.
See all Folotyn indications & dosage >>


Media Articles Related to Folotyn (Pralatrexate)

Burkitt Lymphoma
Source: MedicineNet Cancer Specialty [2015.11.20]
Title: Burkitt Lymphoma
Category: Diseases and Conditions
Created: 11/20/2015 12:00:00 AM
Last Editorial Review: 11/20/2015 12:00:00 AM

First-in-class investigational therapeutic shows early promise for lymphoma patients
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.11.11]
Results from a phase I clinical trial showed that the first-in-class, investigational, anticancer therapeutic pevonedistat was safe, tolerable, and had some anticancer activity in heavily pretreated...

New drug combination suggests promising treatment for mantle cell lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.11.05]
A combination therapy lacking many of the debilitating effects of traditional cancer treatment effectively manages mantle cell lymphoma, shrinking the aggressive and incurable malignancy and...

Hodgkin's and Non-Hodgkin's Lymphoma: Differences and Similarities
Source: MedicineNet Cancer Causes Specialty [2015.11.03]
Title: Hodgkin's and Non-Hodgkin's Lymphoma: Differences and Similarities
Category: Diseases and Conditions
Created: 1/31/2007 12:00:00 AM
Last Editorial Review: 11/3/2015 12:00:00 AM

Scientists find possible genetic key to why some lymphoma patients don't respond to treatment
Source: Blood / Hematology News From Medical News Today [2015.11.02]
An important regulator that controls the ability of tumour cells to hide from the immune system in lymphoma patients, making them unlikely to respond to standard treatment, has been discovered by...

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Published Studies Related to Folotyn (Pralatrexate)

Pralatrexate with vitamin supplementation in patients with previously treated, advanced non-small cell lung cancer: safety and efficacy in a phase 1 trial. [2011.11]
INTRODUCTION: Pralatrexate is an antifolate designed for preferential tumor cell uptake and accumulation and received accelerated Food and Drug Administration approval in relapsed/refractory peripheral T-cell lymphoma. Pralatrexate 135 to 150 mg/m(2) every 2 weeks without vitamin supplementation was active in non-small cell lung cancer (NSCLC) although mucositis was dose limiting. This phase 1 study evaluated the safety of higher pralatrexate doses with vitamin supplementation to minimize toxicities... CONCLUSIONS: Pralatrexate with vitamin supplementation was safely administered to patients with previously treated NSCLC, and durable responses were observed. The recommended starting dose for phase 2 is 190 mg/m(2). A similar safety profile was observed in patients treated at 230 mg/m(2), although a higher serious AE rate was evident. Mucositis remains the dose-limiting toxicity of pralatrexate, and this study failed to demonstrate that vitamin supplementation prevents mucositis and failed to identify clinical predictors of mucositis. Individualized dose-modification strategies and prospective mucositis management will be necessary in future trials.

Pralatrexate: A novel synthetic antifolate for relapsed or refractory peripheral T-cell lymphoma and other potential uses. [2011.09.26]
CONCLUSION: PDX provides clinical benefit to patients with relapsed or refractory PTCL with durable complete and partial responses in patients who had not responded to multiple prior treatment regimens.

Evaluation of the pharmacokinetics, preclinical and clinical efficacy of pralatrexate for the treatment of T-cell lymphoma. [2011.09]
INTRODUCTION: Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of T-cell neoplasms. Most patients with PTCL have a poor outcome with conventional therapies and are not cured without stem-cell transplantation... The most frequent adverse events in these trials were mucositis, reversible thrombocytopenia and fatigue.

Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. [2011.03.20]
PURPOSE: Peripheral T-cell lymphoma (PTCL) is a poor prognosis subtype of non-Hodgkin's lymphoma with no accepted standard of care. This study evaluated the efficacy and tolerability of pralatrexate, a novel antifolate with promising activity... CONCLUSION: To our knowledge, PROPEL (Pralatrexate in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma) is the largest prospective study conducted in patients with relapsed or refractory PTCL. Pralatrexate induced durable responses in relapsed or refractory PTCL irrespective of age, histologic subtypes, amount of prior therapy, prior methotrexate, and prior autologous stem-cell transplant. These data formed the basis for the US Food and Drug Administration approval of pralatrexate, the first drug approved for this disease.

Single agent and combination studies of pralatrexate and molecular correlates of sensitivity. [2011.01.18]
BACKGROUND: Pralatrexate is a dihydrofolate reductase (DHFR) inhibitor with high affinity for reduced folate carrier 1 (RFC-1) and folylpolyglutamate synthetase (FPGS), resulting in extensive internalization and accumulation in tumour cells. Pralatrexate is approved in the US for the treatment of relapsed or refractory peripheral T-cell lymphoma and is being investigated in various malignancies. Here, we evaluated molecular correlates of sensitivity to pralatrexate and explored combinations with a variety of anticancer agents... CONCLUSION: Pralatrexate was more potent than methotrexate in a panel of solid tumour lines. Our findings support the further clinical development of pralatrexate in combination with certain cytotoxics and targeted therapies, and suggest that RFC-1, FPGS and DHFR may be potential biomarkers of outcome.

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Clinical Trials Related to Folotyn (Pralatrexate)

Phase 2, Single Arm, Open Label Study of Folotyn in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With PTCL [Recruiting]

Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn [Withdrawn]
The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.

Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn® [Withdrawn]
To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.

Study of Pralatrexate vs. Erlotinib for Non-Small Cell Lung Cancer After at Least 1 Prior Platinum-based Treatment [Completed]
The purpose of this clinical study is to determine the effectiveness (ability to provide beneficial treatment of the disease) and safety of pralatrexate compared to erlotinib when given to non-small cell lung cancer (NSCLC) patients who are current or former cigarette smokers and who have received at least 1 prior treatment with a platinum drug (cisplatin or carboplatin)

Erlotinib in Combination With Pralatrexate in Advanced Malignancies [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied. Pralatrexate is designed to block the body's ability to make folic acid, a protein that may help cancer tissue to develop and spread. Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells to grow. Erlotinib may help slow the growth of tumors.

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Reports of Suspected Folotyn (Pralatrexate) Side Effects

Febrile Neutropenia (5)Mucosal Inflammation (5)Disease Progression (4)Blister (4)Platelet Count Increased (3)Device Related Infection (3)Abdominal Pain Upper (3)Acute Respiratory Distress Syndrome (3)Thrombocytopenia (3)Stomatitis (3)more >>

Page last updated: 2015-11-20

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