Module 9 2021

22/03/2021

EXTRAPOLATION

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EXTRAPOLATION TO OTHER USES?

• Extrapolation accepted in guidelines in EU, USA, Canada and Japan • Requires adequate justification • Immunomodulator and anticancer (cytotoxic) antibody, extrapolation more challenging (CHMP Guidance) • Antibody-dependent cytotoxicity (ADCC) appears to be more important in some indications than in others • Should extrapolate immunogenicity findings from sensitive to non sensitive populations: e.g. not immunosuppressed and more liable to produce antibody response

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