Zevalin^® Press Kit

(Ibritumomab Tiuxetan)

Zevalin’s Approved Indication

Zevalin^® (Ibritumomab Tiuxetan), as part of the Zevalin therapeutic regimen, is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL), including patients with rituximab refractory follicular NHL.

(The term refractory refers to lymphoma that does not respond to a particular therapy. The term relapsed refers to lymphoma that returns after initially responding to therapy. The terms low-grade and follicular refer to types of lymphoma cells as determined by laboratory tests.)

The Zevalin therapeutic regimen has been given accelerated approval for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies that have shown durable objective overall response rates, a surrogate endpoint for progression-free survival. Studies to determine whether the Zevalin therapeutic regimen confers an effect on progression-free survival are ongoing.

Zevalin's History

Zevalin was approved by the FDA in February of 2002. CTI completed its acquisition of Zevalin from Biogen Idec in December 2007, giving the company sole responsibility for marketing, sales, and development of the drug in the United States and returning us to a select group of biotech companies that have a commercial product.

What is the Zevalin Therapeutic Regimen?

The Zevalin therapeutic regimen uses a combination of medications or agents given in a specific order over a certain period of time. The Zevalin therapeutic regimen uses two forms of Zevalin and another agent called rituximab (brand name Rituxan^®). Although the regimen involves three different agents, patients may hear doctors and healthcare professionals refer to the Zevalin therapeutic regimen as "Zevalin" for short.

The two forms of Zevalin used in the Zevalin therapeutic regimen are made by combining a monoclonal antibody with a radioisotope. Radioisotopes are atoms that give off or emit energy as radiation. When a drug is combined with a radioisotope, it is said to be radiolabeled. Zevalin can be radiolabeled with two different radioisotopes, In-111 or Y-90. Each of these radioisotopes is used for different reasons (see Frequently Asked Questions about the Zevalin Therapeutic Regimen, page 13). Each of the three agents used in the Zevalin therapeutic regimen are given through an intravenous (IV) infusion or injection. These agents are: rituximab, In-111 Zevalin (Zevalin + the radioisotope, Y-90 Zevalin (Zevalin + the radioisotope Y-90).

Each of these agents has a specific purpose and must be given in a specific order and timeframe. The entire Zevalin therapeutic regimen is given over a period of 7 to 9 days.

Zevalin is available by prescription only.

Zevalin in Clinical Development

ADVERSE REACTIONS
The most common adverse reactions (40% or greater) are neutropenia, thrombocytopenia, anemia, asthenia, and gastrointestinal symptoms.