Provectus Biopharmaceuticals Reaffirms Commitment to Bring PV-10 to Market


The FDA will not to give PV-10 breakthrough therapy designation for treatment of patients with locally advanced cutaneous melanoma, because the data did not prove substantial over existing therapies. However, Provectus Biopharmaceuticals says it is still committed to bringing the investigational melanoma therapy to market.

The FDA decision stated, "We have reviewed your request and while we have determined that treatment of ‘locally advanced cutaneous melanoma' meets the criteria for a serious or life-threatening disease or condition, the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Therefore, designation as a Breakthrough Therapy cannot be granted at this time.” A copy of the Agency's notification letter will be filed as an attachment to a SEC form 8-K. The clinical data submitted in the request will be presented at the American Society of Clinical Oncology (ASCO) annual meeting on Monday, June 2. Further data may cause the Agency to revisit this decision at a later date.

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