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Two DOXIL(R) Studies to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

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.



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


-- Accidental substitution has resulted in severe side effects. Do not

substitute for doxorubicin HCl on a mg per mg basis


-- 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


-- 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


-- DOXIL can cause fetal harm when used during pregnancy

-- Recall reaction has occurred with DOXIL administration after


-- 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, 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

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

NOTE: This release corresponds to ASCO abstracts 8562 and 8563 and publication number 20505.

SOURCE Ortho Biotech
Copyright©2008 PR Newswire.
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