On March 24, 2014 Provectus Biopharmaceuticals reported that it has applied to the US FDA for Breakthrough Therapy Designation (BTD) for PV-10 for the treatment of melanoma (Press release Provectus Pharmaceuticals, MAR 24, 2014, http://www.pvct.com/pressrelease.html?article=20140324 [SID:1234500316]). FDA guidelines state that the Agency will make a decision on the application within 60 days of receipt. The Agency’s records for FY 2013 show that the Agency’s Center for Drug Evaluation and Research (CDER) met that guideline 97% of the time.
Craig Dees, PhD, CEO of Provectus said, “The decision to apply for BTD stems from our Type C meeting held with the FDA’s Division of Oncology Products 2 in December 2013. At the meeting FDA expressed willingness to work with Provectus toward initial approval for the novel investigational oncology drug PV-10 in locally advanced cutaneous melanoma. This included a statement in the minutes that data in a cohort of patients that received PV-10 to all existing lesions should be submitted in a formal BTD application.”