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news.Biotechnology company Celsion has said that in conjunction with its Phase III primary liver cancer protocol submission under the SPA Guidance, the FDA has requested an update to the study's radiology charter.
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Michael Tardugno, president and CEO, said: “The FDA’s request is consistent with the SPA process and does not in any way suggest that approvability of our pivotal study is at issue. We have confidence in our submission and we are appreciative of the agency’s collaboration with Celsion in order to expedite their review of our application.”
ThermoDox is a proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anticancer drug used in the treatment of various cancers including breast cancer.