Zevalin™ Kit manufactured by IDEC Pharmaceuticals BLA 125019 September 11, 2001 FDA Presentation to the Oncologic Drugs Advisory Committee.

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Presentation transcript:

Zevalin™ Kit manufactured by IDEC Pharmaceuticals BLA September 11, 2001 FDA Presentation to the Oncologic Drugs Advisory Committee

Review Committee Product/Committee Chair:Marjorie Shapiro, Ph.D. Clinical Reviewers:Philippe C. Bishop, M.D. George Mills, M.D. Biostatistician:Satish C. Misra, Ph.D. Clinical Toxicology/ Pharmacology: Dave Green, Ph.D. Compliance/BIMO:Mary Andrich, M.D. Product Reviewer: Leon Epps, Ph.D. CMC Reviewers:Deborah Trout, B.S. Kevin O’Brien, B.A. Regulatory Project Manager: Michael Noska, M.S.

Characteristics of 2B8 Murine IgG1,  (Ibritumomab) anti-CD20 Manufactured by standard tissue culture and purification procedures Conjugated with MX-DTPA (tiuxetan) chelate Ibritumomab tiuxetan packaged in kits for radiolabeling with 111 Indium or 90 Yttrium (Zevalin™)

Ibritumomab tiuxetan Structure N CO 2 H CH 3 N CO 2 H N NHNH C S HNHN 2B8 mAb Linker/Chelator; MX-DTPA

 Ibritumomab tiuxetan  50 mM Sodium Acetate  Formulation buffer  Reaction vial Zevalin  Kit Components

Preparation of Radiolabeled- Zevalin   Ordering of 111 In from approved source  Coordinated ordering of 111 In– and 90 Y-Zevalin  Kits and 90 Y through distributor  Final 111 In- and 90 Y-labeled Zevalin  are prepared on site at radiopharmacy

Zevalin  Therapy Components  Step 1 Rituximab 111 In-Zevalin   Step 2 Rituximab 90 Y-Zevalin 

Proposed Indication For the treatment of patients with relapsed or refractory low grade, follicular or CD20+ transformed B cell Non- Hodgkin’s lymphoma (NHL) and rituximab refractory follicular NHL