IMPORTANT SAFETY INFORMATIONPRESCRIBING INFORMATION

FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R 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.

PROPEL—the pivotal pralatrexate trial

The first large, prospective, multicenter, single-arm, open-label, international trial conducted for relapsed/refractory PTCL1,2

The PROPEL trial—Pralatrexate in Patients with Relapsed Or Refractory Peripheral T-cell Lymphoma

  • The PROPEL trial treated 111 patients, of whom 109 had histologically confirmed PTCL and were evaluable for efficacy*†‡
  • PROPEL investigators studied patients from six countries
  • Based on the PROPEL trial, the FDA granted FOLOTYN accelerated approval for the treatment of relapsed or refractory PTCL
PROPEL trial design, inclusion criteria, primary endpoint, and secondary endpoint
  • * 115 were enrolled
  • † Assessed by independent central review using the Revised European American Lymphoma (REAL)
       World Health Organization (WHO) disease classification
  • ‡ The median time from initial diagnosis to study entry was 15.6 months (range=0.8–322.3)
  • ECOG: Eastern Cooperative Oncology Group
  • CR: complete response
  • CRu: complete response unconfirmed
  • PR: partial response
  • IWC: International Workshop Criteria

Selected Safety Information

Use in Specific Populations

  • Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.
  • The FOLOTYN dose is reduced for patients with severe renal impairment (eGFR 15 to <30 mL/min/1.73 m2). For patients with mild to moderate renal impairment, dose reduction is not necessary.

PROPEL trial—Patient demographics1,2*

PROPEL trial patient demographics chart (gender, age, and region site)

* The median time from initial diagnosis to study entry was 15.6 months (range=0.8–322.3)
Of the 111 patients treated, 109 patients were evaluable for efficacy

Selected Safety Information

Warnings and Precautions

  • FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit and/or reduce dose for hematologic toxicities.

References:

  • Folotyn [package insert]. Westminster, CO: Allos Therapeutics, Inc.
  • Data on file. Spectrum Pharmaceuticals, Inc.