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FDA Presentation to the Oncologic Drugs Advisory Committee

FDA Presentation to the Oncologic Drugs Advisory Committee. Zevalin ™ Kit manufactured by IDEC Pharmaceuticals BLA 125019 September 11, 2001. Review Committee. Product/Committee Chair: Marjorie Shapiro, Ph.D. Clinical Reviewers: Philippe C. Bishop, M.D. George Mills, M.D.

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FDA Presentation to the Oncologic Drugs Advisory Committee

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  1. FDA Presentationto theOncologic Drugs Advisory Committee Zevalin™ Kit manufactured by IDEC Pharmaceuticals BLA 125019 September 11, 2001

  2. 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.

  3. Characteristics of 2B8 • Murine IgG1, k (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 111Indium or 90Yttrium (Zevalin™)

  4. CO2H CO2H N N H N CH3 N N H CO2H 2B8 C CO2H CO2H S Ibritumomab tiuxetan Structure mAb Linker/Chelator; MX-DTPA

  5. Zevalin Kit Components • Ibritumomab tiuxetan • 50 mM Sodium Acetate • Formulation buffer • Reaction vial

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

  7. Zevalin Therapy Components • Step 1 • Rituximab • 111In-Zevalin • Step 2 • Rituximab • 90Y-Zevalin

  8. 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

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