TY - JOUR
T1 - The FDA Guidance on therapeutic cancer vaccines
T2 - The need for revision to include preventive cancer vaccines or for anewguidance dedicated to them
AU - Finn, Olivera J.
AU - Khleif, Samir N.
AU - Herberman, Ronald B.
N1 - Publisher Copyright:
© 2015 AACR.
PY - 2015/11
Y1 - 2015/11
N2 - Cancer vaccines based on antigens derived from self molecules rather than pathogens have been under basic and clinical investigations for many years. Up until very recently, they had been tested primarily in the setting of metastatic disease with the goal to engage the immune system in slowing down disease progression. Many therapeutic vaccine trials, either investigator initiated or led by pharmaceutical companies, have been completed and many are currently ongoing, following the FDA Guidance on therapeutic cancer vaccines published in 2011. In recent years, the target of cancer vaccines is being shifted to early cancer and even premalignant disease with the goal of preventing cancer. Although some issues addressed in the FDA Guidance on therapeutic vaccines apply to preventive vaccines, many do not. Here, we discuss a set of recommendations for revising the current Guidance to also cover preventive vaccines, or to include in a new Guidance dedicated specifically to vaccines for cancer prevention.
AB - Cancer vaccines based on antigens derived from self molecules rather than pathogens have been under basic and clinical investigations for many years. Up until very recently, they had been tested primarily in the setting of metastatic disease with the goal to engage the immune system in slowing down disease progression. Many therapeutic vaccine trials, either investigator initiated or led by pharmaceutical companies, have been completed and many are currently ongoing, following the FDA Guidance on therapeutic cancer vaccines published in 2011. In recent years, the target of cancer vaccines is being shifted to early cancer and even premalignant disease with the goal of preventing cancer. Although some issues addressed in the FDA Guidance on therapeutic vaccines apply to preventive vaccines, many do not. Here, we discuss a set of recommendations for revising the current Guidance to also cover preventive vaccines, or to include in a new Guidance dedicated specifically to vaccines for cancer prevention.
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U2 - 10.1158/1940-6207.CAPR-15-0234
DO - 10.1158/1940-6207.CAPR-15-0234
M3 - Article
C2 - 26353948
AN - SCOPUS:84946149039
SN - 1940-6207
VL - 8
SP - 1011
EP - 1016
JO - Cancer Prevention Research
JF - Cancer Prevention Research
IS - 11
ER -