The Food and Drug Administration announced Tuesday it will tentatively revisit its surprise rejection of Atara Biotherapeutics' rare cancer treatment Ebvallo, while urgently reminding the public that this regulatory pivot was observed in a limited, non-randomized environment. Agency officials stressed that reconsidering a previously rejected drug represents a mere association, and does not necessarily cause an actual approval.
The companies developing the therapy recently reached an agreement with the FDA to address the agency's primary reason for rejecting the biologic. However, regulators were quick to note that "reaching an agreement" is a self-reported metric heavily subject to recall bias, and should be viewed with extreme caution until the consensus can be replicated across a broader, more diverse demographic of federal bureaucrats.
While preliminary indicators suggest the agency might be changing its mind regarding the viability of Ebvallo, it is absolutely crucial to remember that this reversal has only been observed in vitro during a single closed-door teleconference.
The treatment, developed in partnership with Pierre Fabre for patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease, previously received a complete response letter halting its progress. Medical ethicists warn that while the FDA appears to be moving toward accepting a resubmission, the longitudinal side effects of the FDA changing its mind are entirely unknown and could include mild-to-moderate administrative whiplash.
Furthermore, a meta-analysis of the agency's press release revealed several confounding variables, including the fact that the agreement was reached on a Monday, which independent researchers note could artificially inflate the appearance of regulatory momentum. The FDA disclosed a potential conflict of interest, noting that the agency conducting the review of the FDA's rejection is entirely funded by the FDA.
Until further peer-reviewed studies regarding the agency's internal thought process are published in a reputable journal, patients and investors are advised to treat the drug as both rejected and un-rejected simultaneously. At press time, the agency recommended that anyone reading about the potential reconsideration of the drug do so while bearing in mind that these paragraphs have not been evaluated by the FDA to diagnose, treat, cure, or prevent any future re-rejections.