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Provectus Breakthrough Denial Is Symptom Of a Different Breakthrough at FDA

 
• By Cole Werble

Provectus Pharmaceuticals raised a few eyebrows by raising the curtain on FDA’s rejection of its Breakthrough status application for its malignant melanoma drug. By making the letter public, the company shed light on the broader issue of how seriously FDA is taking symptom improvement as a component of clinical meaningfulness in some cancers.

Symptom endpoints matter in oncology. That’s one of the background messages in FDA’s May 16 rejection of Provectus Biopharmaceuticals Inc.’s request for Breakthrough status for PV-10 (rose Bengal disodium in 0.9% saline) for use against locally advanced cutaneous melanoma.

FDA Division of Oncology Products 2 Director Patricia Keegan explained FDA’s denial of Breakthrough status by citing a “paucity of data on endpoints indicative of clinical benefit.”

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