BRIDGEWATER, N.J., May 29 NJ-Doxil-studies
BRIDGEWATER, N.J., May 29 /PRNewswire/ -- Ortho Biotech today announced
that two clinical studies for DOXIL(R) (doxorubicin HCl pegylated liposome
injection) will be presented at the 44th American Society of Clinical Oncology
(ASCO) Annual Meeting at McCormick Place in Chicago from May 30 to June 3,
2008.
"We are pleased that ASCO has accepted these data for presentation at the
annual meeting," said Craig Tendler, M.D., Vice President, Medical Affairs,
Oncology/Nephrology, Ortho Biotech Products, L.P. "Through our ongoing
investigation of DOXIL, Ortho Biotech is committed to oncology clinical
research and helping patients fight cancer."
Data from the following studies will be presented:
-- The Effect of Pegylated Liposomal Doxorubicin Plus Bortezomib in
Multiple Myeloma Patients with Renal Insufficiency (Abstract 8562)
Presentation: Saturday, May 31, 8:00 am - 12:00 pm CST, General
Poster Session: Lymphoma and Plasma Cell Disorders, S Hall A1,
Poster 47A
Authors: J. Blade, P. Sonneveld, J. San Miguel, H. Sutherland,
R. Hajek, A. Nagler, A. Spencer, T. Robak, J. L. Harousseau,
R. Z. Orlowski, The DOXIL-MMY-3001 Study Investigators
-- Phase II Trial of Pegylated Liposomal Doxorubicin (PLD), Rituxan,
Cyclophosphamide, Vincristine, and Prednisone in Aggressive B-Cell
Non-Hodgkin's Lymphoma (Abstract 8563)
Presentation: Saturday, May 31, 8:00 am - 12:00 pm CST, General
Poster Session: Lymphoma and Plasma Cell Disorders, S Hall A1,
Poster 47B
Authors: H. Gu, A. Tulpule, N. Berman, C. Duran, S. G. Groshen,
L. Buchanan, W. Boswell, B. Nathwani, A. M. Levine
In addition, the following study was accepted for publication:
-- Activity and Toxicity of Pegylated Liposomal Doxorubicin in
Combination Regimen (DRCOP) for Patients >60 Years Old With Untreated
Diffuse Large B-Cell Lymphoma (DLBCL): A Phase II Study
(Abstract 20505)
Publication only
Authors: M. A. Rodriguez, M. Fanale, F. B. Hagemeister,
P. McLaughlin, B. Pro, J. E. Romaguera, L. Kwak, L. E. Fayad,
J. Durand
About DOXIL(R)
DOXIL is indicated in combination with VELCADE(R) (bortezomib) for the
treatment of patients with multiple myeloma who have not previously received
VELCADE and have received at least one prior therapy, and for the treatment of
patients with ovarian cancer whose disease has progressed or recurred after
prior platinum based therapy.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS
Cardiotoxicity, infusion reaction, myelosuppression, liver impairment,
Substitution
-- The use of DOXIL may lead to cardiac toxicity. Myocardial damage may
lead to congestive heart failure and may occur as the total
cumulative dose of doxorubicin HCl approaches 550 mg/m2
-- Prior use of other anthracyclines or anthracenediones should be
included in calculations of total cumulative dose
-- Cardiac toxicity may also occur at lower cumulative doses
(400 mg/m2) in patients with prior mediastinal irradiation or
who are receiving concurrent cyclophosphamide therapy
-- Acute infusion-related reactions including, but not limited to,
flushing, shortness of breath, facial swelling, headache, chills,
back pain, tightness in the chest or throat, and/or hypotension have
occurred in up to 10% of patients treated with DOXIL. In most
patients, these reactions have resolved within several hours to a day
once the infusion is terminated. In some patients, reactions resolved
with slowing of the infusion rate
-- Serious and sometimes life-threatening or fatal
allergic/anaphylactoidlike infusion reactions have occurred.
Medications to treat such reactions, as well as emergency
equipment, should be available for immediate use
-- The initial rate of infusion should be 1 mg/min to minimize the
risk of infusion reactions
-- Severe myelosuppression may occur
-- DOXIL dosage should be reduced in patients with impaired hepatic
function
-- Accidental substitution has resulted in severe side effects. Do not
substitute for doxorubicin HCl on a mg per mg basis
Contraindications
-- Patients with a history of hypersensitivity reactions to a
conventional doxorubicin formulation or the components of DOXIL
-- Nursing mothers
Additional Safety Information
-- Cardiac function should be carefully monitored
-- Congestive heart failure or cardiomyopathy may occur after
discontinuation of anthracycline therapy
-- For patients with a history of cardiovascular disease, or if the
results of cardiac monitoring indicate possible cardiac injury,
the benefit of therapy must be weighed against the risk of
myocardial injury
-- In the randomized multiple myeloma study, 25 patients (8%) in
the VELCADE for Injection arm and 42 patients (13%) in the
VELCADE plus DOXIL arm experienced left ventricular ejection
fraction decrease (defined as absolute decrease greater than or
equal to 15% over baseline or a greater than or equal to 5%
decrease below institutional lower limit of normal)
-- Myelosuppression may occur; frequently monitor complete blood count
(including platelet count), at least prior to each dose of DOXIL
-- In patients with multiple myeloma, hematologic toxicity (based
on platelet count, absolute neutrophil count, hemoglobin level,
or neutropenia with fever) may require dose reduction, delay in
administration, or suspension of DOXIL and/or VELCADE
-- Persistent severe myelosuppression may result in superinfection,
neutropenic fever, or hemorrhage
-- Sepsis occurring during neutropenia has resulted in
discontinuation of treatment and in rare cases of death
-- DOXIL may potentiate the toxicity of other anticancer therapies,
especially hematologic toxicities, when used in combination with
other therapies that suppress bone marrow
-- Hand-foot syndrome (HFS) may occur during therapy with DOXIL
-- Based on HFS toxicity grade, dose reduction, delay in
administration, or discontinuation of DOXIL may be required
-- HFS was generally observed after 2 to 3 cycles of treatment,
but may occur earlier
-- The reaction was mild in most patients, resolving in 1 to 2
weeks
-- The reaction can be severe and debilitating in some
patients, resulting in discontinuation of therapy
-- DOXIL is an irritant, not a vesicant; use precautions to avoid
extravasation
-- DOXIL can cause fetal harm when used during pregnancy
-- Recall reaction has occurred with DOXIL administration after
radiotherapy
-- DOXIL may interact with drugs known to interact with the
conventional formulation of doxorubicin HCl
-- In patients with multiple myeloma, the most common all-grade ARs
greater than or equal to 20% (VELCADE plus DOXIL vs VELCADE,
respectively) included: neutropenia (36% vs 22%),
thrombocytopenia (33% vs 28%), anemia (25% vs 21%), fatigue
(36% vs 28%), pyrexia (31% vs 22%), asthenia (22% vs 18%),
nausea (48% vs 40%), diarrhea (46% vs 39%), vomiting (32% vs
22%), constipation (31% vs 31%), mucositis/stomatitis (20% vs
5%), peripheral neuropathy (42% vs 45%), neuralgia (17% vs 20%),
and rash (22% vs 18%)
-- In addition, 19% vs <1% reported HFS
Please see full Prescribing Information
http://www.doxil.com/pdf/DOXIL_PI_Booklet.pdf, including Boxed WARNINGS.
DOXIL is marketed in the United States by Ortho Biotech Products, L.P.,
and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a
licensing agreement, has exclusive rights to market the medication as CAELYX
throughout the rest of the world, excluding Japan and Israel. For more
information about DOXIL, please visit www.DOXIL.com.
About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company
devoted to helping improve the lives of patients with cancer and with anemia
due to multiple causes, including chronic kidney disease. Since it was
founded in 1990, Ortho Biotech and its worldwide affiliates have earned a
global reputation for researching, manufacturing and marketing innovative
products that enhance patients' health. Located in Bridgewater, N.J., Ortho
Biotech is an established market leader in Epoetin alfa therapy for anemia
management. The company also markets treatments for recurrent ovarian cancer,
rejection of transplanted organs and other serious illnesses. For more
information, visit www.orthobiotech.com.
NOTE: This release corresponds to ASCO abstracts 8562 and 8563 and
publication number 20505.
SOURCE Ortho Biotech
