Provectus receives FDA guidance for late-stage trial of melanoma drug

Drug maker gets set for phase-3 trial of PV-10

KNOXVILLE, Tenn. — The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.

Provectus is planning to start a phase-3 trial of the investigational drug PV-10 for melanoma that has spread to other parts of the body, and said the FDA told the company that a meeting with the agency in addition to the one they had in October would not be required.

"Following our third meeting with the agency in October, we believed that significant progress had been achieved in defining the threshold the FDA will require for approval in melanoma, which is a rapidly evolving therapeutic area," Provectus CEO Craig Dees said.


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