ASH News Daily - Sunday, December 11, 2011 - (Page B-5)

FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. The indication for FOLOTYN is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. BE THREADY WI FO LOT YN (pralatrexate injection) Demonstrated response in relapsed or refractory PTCL1 / When PTCL Returns... response rate 27% overall Of the responders, responded within Cycle 1* — Median time to first response was 45 days (range=37–349 days) 66% (CR+CRu+PR) by independent central review (95% CI, 19–36)* Important Safety Information duration of response by central review (range=1–503 days)* —12% (95% CI, 7–20) of patients had responses lasting ≥14 weeks (range=98–503 days) 9.4-month median Demonstrated response in PROPEL— the first large, prospective, single-arm, open-label clinical trial in PTCL 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 Populations 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 of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance. Please see FOLOTYN Full Prescribing Information. *Per independent central review Reference: 1. FOLOTYN Prescribing Information. Allos Therapeutics, Inc., 2011. 11080 CirclePoint Road, Suite 200 Westminster, CO 80020 www.allos.com ©2011 Allos Therapeutics, Inc. 5/11 Printed in USA FOL-1184-11 Please see accompanying brief summary of Prescribing Information. www.FOLOTYN.com 10/19/11 1:07 PM ALL-11-0506_FOL-1184-11_ASH.indd 1

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ASH News Daily - Sunday, December 11, 2011

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