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Oncopeptides announces regulatory update from the FDA

Marty Duvall

The US Food and Drug Administration, FDA, has issued a safety alert to patients and health care professionals, regarding an increased risk of death associated with Pepaxto (melphalan flufenamide), in the OCEAN study.

The company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes availabl, it states.

The company also plans to submit complete data from the OCEAN-study to the International Myeloma Workshop meeting in Vienna on September 8-11, 2021.

Photo of Marty Duvall, CEO, Oncopeptides