Therapeutic Cancer Vaccines Can Use Adjuvants, FDA Says
But even though the agency’s final guidance on cancer vaccines adds a section on adjuvants, the additional data requirements that FDA will request remain relatively vague.
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Vindicated by the approvals of Provenge and Yervoy, a host of therapeutic cancer vaccines is working through late-stage trials with the regulatory finish line in sight, and some of those companies will be presenting data at the American Society of Clinical Oncology meeting in Chicago June 1-5.
Industry is calling on FDA to write separate rules for assessing adjuvants. This would encourage innovation in immunotherapies, the Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America contend.
House appropriators are pressing FDA to license adjuvanted seasonal influenza vaccines that have a proven safety record.