Patrick Soon-Shiong, Chairman of Chan Soon-Shiong Family Foundation, Executive Chairman at ImmunityBio, and Executive Chairman of the Los Angeles Times, shared post on X:
“In light of these prospective findings that ALC affects survival, we will be working with FDA to explore the question that based on ANKTIVA’s already approved mechanism of action could it be considered a supportive therapy ( like EPO) if given in conjunction with any current standard of care and not replacing the therapy being considered by the doctor to support and maintain the lymphocytes during the standard of care treatment ?
In so doing if given as an adjunct to any standard of care therapy and not replacing the current standard of care chosen by the treating oncologist, it would be a Hematologic Support Therapy and would relate to Anktiva’s ability to maintain NK and T cell count and not to its affect on efficacy since the efficacy would be based on the standard of care across all tumor types!
That is how EPOGEN supports the number of red blood cells and NUEPOGEN supports the neutrophils and is reviewed by the Division of non- oncology Hematological division.”
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