Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that
data on FOLOTYN® (pralatrexate injection) will be presented at two
upcoming international medical conferences: the 16th Congress of
the European Hematology Association (EHA) in London, England from
June 9-12, and the 11th International Conference on Malignant
Lymphoma (ICML) in Lugano, Switzerland from June 15-18.
“Allos is looking forward to the presentation of FOLOTYN data at
both EHA and ICML as these analyses provide further support and
expand our understanding of FOLOTYN as a single-agent for the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma and as a potential combination therapy in cutaneous T-cell
lymphoma,” said Charles Morris, MB ChB, MRCP, chief medical officer
at Allos Therapeutics, Inc. “In addition, the first presentation of
data from COMPLETE – a global peripheral T-cell lymphoma registry
expected to provide greater insight into the treatment patterns and
outcomes for patients with this type of T-cell lymphoma where there
remains a high global unmet treatment need – will also be
presented.”
FOLOTYN, a folate analogue metabolic inhibitor, is the first and
only drug approved in the U.S. for the treatment of patients with
relapsed or refractory peripheral T-cell lymphoma (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 December 2010, Allos announced that the
Company’s Marketing Authorisation Application (MAA), seeking
approval of FOLOTYN for the treatment of patients with relapsed or
refractory PTCL, was accepted by the European Medicines Agency
(EMA).
Information regarding the key presentation at EHA is as
follows:
Abstract Title: “Pralatrexate
Selectively Induces Apoptosis and Synergizes with Bexarotene
Through Up-Regulation of p53/Bax/PUMA in Cutaneous T-cell Lymphoma
Cells”Abstract Number: 405Presentation Date/Time:
Friday, June 10, 17:45-19:00 CET
Information regarding the presentations at ICML is as
follows:
Abstract Title: “Pralatrexate
Reverses the Trend in Progressive Resistance with Successive
Chemotherapy Regimens in the Treatment of Relapsed or Refractory
Peripheral T-cell Lymphoma (PTCL)”Abstract Number:
361Presentation Date/Time: Friday, June 17, 08:30-18:30
CET
Abstract Title:
“Pralatrexate, an Effective Single-Agent Second-Line Treatment
Following Failure of
Cyclophosphamide/Doxorubicin/Vincristine/Prednisone (CHOP) in
Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma
(PTCL)”Abstract Number: 360Presentation Date/Time:
Friday, June 17, 08:30-18:30 CET
Abstract Title:
“Comprehensive Oncology Measures for Peripheral T-cell Lymphoma
Treatment (COMPLETE), a New International Treatment
Registry”Abstract Number: 242Presentation Date/Time:
Thursday, June 16, 08:30-18:30 CET
About Peripheral T-Cell Lymphoma
T-cell lymphomas comprise a biologically diverse group of blood
cancers that account for approximately 10% to 15% of all cases of
non-Hodgkin lymphomas (NHL).1-3 Allos estimates the current annual
incidence of PTCL to be approximately 5,900 patients in the U.S.
and approximately 6,000-7,000 patients in the top five European
markets. The outcome of patients with PTCL is poor and the majority
of patients ultimately have refractory disease to a variety of
agents, including multi-agent chemotherapy with CHOP
(cyclophosphamide, doxorubicin, vincristine, and prednisone) or
CHOP-like regimens. The 5-year overall survival rate in these
patients is 25% to 40%, depending on sub-type.4-5
About FOLOTYN
FOLOTYN, a folate analogue metabolic inhibitor, was discovered
by Sloan-Kettering Institute for Cancer Research, SRI International
and Southern Research Institute and developed by Allos
Therapeutics. In September 2009, the U.S. Food and Drug
Administration (FDA) granted accelerated approval for FOLOTYN for
use as a single agent for the treatment of patients with relapsed
or refractory 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 has
been available to patients in the U.S. since October 2009.
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. Allos is currently focused on
the development and commercialization of FOLOTYN® (pralatrexate
injection), a folate analogue metabolic inhibitor. FOLOTYN is the
first and only drug approved in the U.S. for the treatment of
patients with relapsed or refractory PTCL. Allos is also developing
FOLOTYN in other hematologic malignancies and solid tumors. For
additional information, please visit www.allos.com.
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 are 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 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 at
www.FOLOTYN.com.
Note: The Allos logo and FOLOTYN name are trademarks of Allos
Therapeutics, Inc.
Source: Allos Therapeutics, Inc.
References:
1. The Non-Hodgkin's Lymphoma Classification
Project. A clinical evaluation of the International Lymphoma Study
Group classification of non-Hodgkin's lymphoma. Blood.
1997;89(11):3909-3908. 2. Hennessy BT, Hanrahan EO, Daly PA.
Non-Hodgkin lymphoma: an update [review]. Lancet Oncol.
2004;5(6):341-353. 3. O'Leary HM, Savage KJ. Novel therapies in
peripheral T-cell lymphomas [review]. Curr Oncol Rep.
2008;134(5):202-207. 4. Savage KJ, Chhanabhai M, Gascoyne RD, et
al. Characterization of peripheral T-cell lymphomas in a single
North American institution by the WHO classification. Ann Oncol
2004;15(10):1467-75. 5. Savage KJ. Peripheral T-cell Lymphomas.
Blood Rev. 2007; 21:201-216.
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