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.

In a heavily pretreated and relapsed/refractory population, single-agent FOLOTYN demonstrated response

FOLOTYN delivered a 27% overall response rate (CR + CRu + PR) (95% CI, 19––36) in R/R PTCL1,2

RESPONSE RATE (N=109)

Overall response rate: 27%; Partial response rate: 18%; Complete response rate: 8%

Selected Safety Information

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.

Nearly 2/3 of FOLOTYN responders experienced first-cycle response1

TIME TO RESPONSE

66% of responses occurred in the first cycle

Selected Safety Information

Warnings and Precautions

  • Dermatologic reactions, including fatal reactions, have occurred and may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and omit, and/or reduce dose or discontinue FOLOTYN.

FOLOTYN delivered over 9 months median duration of response

FOLOTYN provided a 9.4-month median duration of response (95% CI, 19––36; range=1––503 days)1,2*

MEDIAN DURATION OF RESPONSE

Response assessments were scheduled at the end of Cycle 1 and then every other cycle (every 14 weeks)

Selected Safety Information

MOST COMMON ADVERSE REACTIONS

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.

References:

  • FOLOTYN Prescribing Information. Allos Therapeutics, Inc. 2012.
  • Data on file. Allos Therapeutics, Inc.