Folotyn Efficacy

27% overall response rate (CR + CRu + PR) (95% CI, 19-36) in relapsed or refractory patients with peripheral T-cell lymphoma (PTCL).1,2

Folotyn-Demonstrated response

FOLOTYN’s efficacy was established in the first large, prospective, multicenter, single-arm, open-label, international trial ever conducted for relapsed/refractory PTCL: the PROPEL trial1.

The PROPEL trial (Pralatrexate in Patients with Relapsed Or Refractory Peripheral T-cell Lymphoma1,2) was a pivotal Phase 2, multicenter, single-arm, open-label, international trial to determine the safety and efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation.

  • Population:            
    • 111 adult patients were treateda
    • 109 evaluable patients had histologically confirmed PTCLb
  • Inclusion Criteria:                                                                                
    • Relapsed or refractory disease after at least one prior treatment ECOG performance status ≤2
    • Absolute neutrophil count (ANC) ≥1000/μL                   
    • Platelet count ≥100,000/μL (at both screening and within 3 days prior to dosing on Cycle 1, day 1)
  • Weekly Treatment:
    • Pralatrexate 30 mg/m2 IVP once a week x 6 weeks followed by 1 week of rest (7-week cycles)c
  • Primary Endpoint: 
    • Response rate (CR + CRu + PR) as assessed by independent central review using international working group (IWC) criteria. Response assesments were scheduled at the end of cycle 1 and then every 14 weeks (every other cycle).

 

a 115 were enrolled.
b By independent pathology review using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification
c Dose omission or reduction to 20 mg/m2/week for adverse events.
ECOG= Eastern Cooperative Oncology Group; CR=complete response; CRu=complete response unconfirmed; PR=partial response; IWC=International Workshop Criteria.

 

Important Safety Information

Warnings and Precautions

  • FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.
  • Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.
  • Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued.
  • Tumor lysis syndrome may occur. Monitor patients and treat if needed.
  • FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.
  • Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.
  • Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are ≥Grade 3, omit or modify dose.

Adverse Reactions

  • The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.

Use in Specific Patient Population

  • Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.

Drug Interactions

  • Co-administration with probenecid or other drugs that may affect relevant transporter systems (eg, NSAIDs), requires close monitoring for signs of systemic toxicity.

 

Please see FOLOTYN Full Prescribing Information

Reference:
1 FOLOTYN Prescribing Information. Allos Therapeutics, Inc. 2012.
2 Data on file. Allos Therapeutics, Inc..

 
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