Overview of cancer vaccines: considerations for development.

Abstract:

:Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines.

journal_name

Hum Vaccin Immunother

authors

Kudrin A

doi

10.4161/hv.20518

subject

Has Abstract

pub_date

2012-09-01 00:00:00

pages

1335-53

issue

9

eissn

2164-5515

issn

2164-554X

pii

20518

journal_volume

8

pub_type

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