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FDA Approves Two New Indications for First-Line Use of Rituxan(R) (Rituximab) in Patients With Non-Hodgkin's Lymphoma

Posted on: Tuesday, 3 October 2006, 12:00 CDT

NEW YORK, October 3 /PRNewswire/ -- THIS IS A MULTIVU SPECIAL REPORT, BROUGHT TO YOU BY GENENTECH AND BIOGEN IDEC.

NON-HODGKIN'S LYMPHOMA, A CANCER OF THE LYMPHATIC SYSTEM, IS CURRENTLY THE SIXTH MOST FATAL CANCER IN THE U.S. LOW-GRADE LYMPHOMA, A COMMON FORM, IS NOT CURABLE WITH STANDARD CVP CHEMOTHERAPY TREATMENT. BECAUSE RELAPSE IS COMMON IN PEOPLE WITH THIS CHRONIC DISEASE, THERE IS A NEED FOR SHORT- AND LONG-TERM TREATMENT APPROACHES. NOW, THE FDA HAS APPROVED EXPANDED USES OF RITUXAN THERAPY THAT MAY HELP REDUCE THE RISK OF DISEASE PROGRESSION, RELAPSE OR DEATH IN CERTAIN PATIENTS.

DOCTOR HOWARD HOCHSTER, NEW YORK UNIVERSITY: "With these new approvals, Rituxan may be used first-line with CVP chemotherapy or following initial CVP chemotherapy, to reduce the risk of disease progression, relapse or death."

AMONG PATIENTS WITH LOW-GRADE OR FOLLICULAR, CD20-POSITIVE, B-CELL NON-HODGKIN'S LYMPHOMA, RITUXAN IS NOW APPROVED FOR FIRST-LINE TREATMENT WITH CVP CHEMOTHERAPY AND FOR TREATMENT OF PATIENTS WITH STABLE DISEASE OR WHO ACHIEVE PARTIAL OR COMPLETE RESPONSE FOLLOWING FIRST-LINE CVP. FOR MORE INFORMATION ON RITUXAN'S SAFETY PROFILE, PATIENTS SHOULD SPEAK WITH THEIR DOCTORS.

I'M DANIELLE ADDAIR.

For more information on the safety profile of Rituxan, please visit http://www.rituxan.com/.

Rituxan Safety Profile

The safety profile of Rituxan has been established in more than 960,000 patient exposures over a period of nine years.

In non-Hodgkin's lymphoma, the majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like illness, fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema and hypotension. These symptoms vary in severity and generally are reversible with medical intervention.

Severe infusion reactions have been reported in patients treated with Rituxan, some with fatal outcomes in patients with NHL. These severe reactions typically occur during the first infusion. The most severe manifestations and sequelae include pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, and anaphylactic and anaphylactoid events. Patients who develop clinically significant infusion reactions should have their Rituxan infusion discontinued and receive medical treatment.

Acute renal failure requiring dialysis with instances of fatal outcome has been reported in the setting of tumor lysis syndrome following treatment with Rituxan. Severe mucocutaneous skin reactions, some with fatal outcome, have been reported in association with Rituxan treatment. Patients experiencing a severe mucocutaneous reaction should not receive any further infusions and seek prompt medical evaluation. Abdominal pain, bowel obstruction and perforation, in some cases leading to death, were observed in patients receiving Rituxan in combination with chemotherapy for diffuse large B-cell, CD20-positive, NHL. Other serious or potentially life-threatening adverse reactions that have been reported following Rituxan therapy include Hepatitis B reactivation with fulminant hepatitis, other viral infections, and cardiac arrhythmias.

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GENENTECH AND BIOGEN IDEC

CONTACT: FOR STORY INFORMATION, PLEASE CALL: MultiVu Media Relations,1-800-653-5313, EXT. 3 OR EMAIL RADIO@MULTIVU.COM

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

Source: PRNewswire

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