LaViv does appear to work. The cell therapy was reviewed in 2009 by an FDA advisory committee, which voted 11-3 that laViv demonstrated efficacy in the proposed indication. The same panel, however, voted 6-8 against laViv's safety, mainly due to concerns about uncontrolled cell growth or tumor formation resulting from the injection of these growth-happy cells under a patient's skin. A single patient in the laViv's phase III studies did develop basal cell carcinoma at the laViv injection site that the investigator deemed possibly related to the therapy.
FDA rejected laViv in December 2009, telling Fibrocell that it could resubmit for approval after first conducting a safety study to determine the risk that laViv might cause uncontrolled cell growth or tumors.
Fibrocell conducted this safety study and said the results came back benign in laViv's favor. The new safety data were resubmitted to FDA at the end of last year and accepted by FDA for review. The FDA is expected to issue its second approval decision for laViv on June 22.
(DNDN) Provenge is also an autologous, or personalized, cellular therapy, so there is precedence for this type of FDA approval.