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Ortho Biotech Files sNDA for Doxil for the Treatment of Advanced Breast Cancer

BRIDGEWATER, N.J., September 08, 2008 /PRNewswire/ -- Ortho Biotech Products, L.P. today announced that the Company has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the combination of Doxil (doxorubicin HCl liposome injection) and Taxotere (docetaxel)* for the treatment of women with advanced breast cancer who have received prior anthracycline treatment.

The application to the FDA follows the completion of a randomized, parallel-group, open-label, multicenter Phase III clinical trial that evaluated time to progression (TTP) of the disease with combination vs. monotherapy docetaxel treatment. The study met its protocol-specified primary endpoint demonstrating that the Doxil-docetaxel combination had a statistically significant improvement in TTP as compared to docetaxel alone. Secondary endpoints included overall survival, response rates and safety.

"This is an important milestone in the development of Doxil as we continue to demonstrate efficacy and safety of this agent across multiple tumor types," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/Nephrology, Ortho Biotech Products, L.P. "We look forward to working with the FDA throughout the regulatory review process to provide this new Doxil treatment option for advanced stage breast cancer patients who have relapsed after receiving prior anthracycline-containing adjuvant/neoadjuvant therapy."

The study results have been selected for oral presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS) in December. According to the National Cancer Institute, there will be an estimated 184,450 new cases of breast cancer and 40,930 deaths from breast cancer in the United States in 2008.

    * Taxotere is manufactured by Sanofi Aventis.

About Doxil

Doxil is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum based therapy. Doxil in combination with VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy. Doxil is also indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such 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/anaphylactoid-like 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 recurrent ovarian cancer or AIDS-related Kaposi's sarcoma, hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration 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 D

-- 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 recurrent ovarian cancer, the most common all-grade adverse reactions (ARs) greater than or equal to 20% (Doxil vs topotecan, respectively) included: asthenia (40% vs 51%), fever (21% vs 31%), nausea (46% vs 63%), stomatitis (41% vs 15%), vomiting (33% vs 44%), diarrhea (21% vs 35%), anorexia (20% vs 22%), dyspnea (15% vs 23%), HFS (51% vs 1%), and rash (29% vs 12%)

-- In addition, 19% vs 52.3% reported alopecia (all grades)

-- Grade 3/4 hematologic ARs reported in greater than or equal to 5% (Doxil vs topotecan, respectively) were neutropenia (12% vs 76%) and anemia (6% vs 29%)

-- 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 less than 1% reported HFS

-- In patients with AIDS related Kaposi's sarcoma, ARs reported in greater than or equal to 5% of Doxil-treated patients were: neutropenia (ANC less than 1000/mm3, 46%; less than 500/mm3, 11%), anemia (Hb less than 10 g/dL, 58%; less than 8 g/dL, 16%), thrombocytopenia (less than 150,000 platelets/mm3, 61%), nausea (18%), asthenia (7%), fever (8%), alopecia (9%), vomiting (8%), diarrhea (5%), and stomatitis (5%)

Please see accompanying full Prescribing Information, including Boxed WARNINGS.

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 http://www.orthobiotech.com.

Ortho Biotech Products, L.P. is a member of the Johnson & Johnson family of companies.

Forward-Looking Statement

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of the Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.

CONTACT: Media, Kassy McGourty for Ortho Biotech Products, L.P.,+1-908-541-4090, cell, +1-908-377-5873, ; Investors,Louise Mehrotra, +1-732-524-6491, or Lesley Fishman, +1-732-524-3922, bothfor Ortho Biotech Products, L.P. kmcgourt@its.jnj.com

Web site: http://www.orthobiotech.com/

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Posted: September 2008

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