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.

FOLOTYN was studied in heavily pretreated and relapsed/refractory PTCL patients

Many patients treated with FOLOTYN were heavily pretreated

Patients received a median of 3 prior systemic therapies in the median 15.6 months after initial diagnosis (range=1-12). 68% of PROPEL patients received combination chemotherapy or stem cell transplantation prior to treatment with FOLOTYN

Selected Safety Information

Warnings and Precautions

  • Patients with moderate to severe renal function impairment may be at greater risk for increased exposure and toxicity. Monitor patients for renal function and systemic toxicity and adjust dosing accordingly. Avoid FOLOTYN use in patients with end stage renal disease including those undergoing dialysis unless the potential benefit justifies the potential risk.

Many patients treated with FOLOTYN had refractory disease

63% of patients had no evidence of response to their most recent line of prior therapy (range=1-12). 24% of patients had no evidence of response to any prior therapy.

FOLOTYN was studied across diverse subtypes

The PROPEL trial included diverse histologic subtypes
of PTCL2

Histologic subtypes of PTCL include: PTCL-NOS; ALCL, primary systemic type; AITL; Transformed mycosis fungoides; Blastic NK lymphoma (with skin, lymph node, or visceral involvement); T-/NK-cell lymphoma, nasal type; Other

Selected Safety Information

Warnings and Precautions

  • FOLOTYN can cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests and if abnormalities are ≥Grade 3, omit until recovery then reduce dose or discontinue FOLOTYN as required.

PTCL-NOS, ALCL, and AITL are the most
         common subtypes of PTCL3

References:

  • FOLOTYN Prescribing Information. Allos Therapeutics, Inc. 2012.
  • Data on file. Allos Therapeutics, Inc.
  • Vose J, Armitage J, Weisenburger D. International Peripheral T-Cell and Natural killer/T-Cell Lymphoma Study: Pathology Findings and Clinical Outcomes. J Clin Oncol. 2008;26(25):4124-4130.