Brief: Oncopeptides Provides Update From Meeting With FDAs Advisory Committee ODAC

Oncopeptides AB

23/09/2022 07:53

Sept 23 (Reuters) - Oncopeptides AB  ONCO.ST :
    * PROVIDES AN UPDATE FROM THE MEETING WITH FDAS ADVISORY
COMMITTEE
ODAC
    * A MAJORITY OF PANEL CONSIDERED THAT OCEAN DID NOT CONFIRM
A
FAVORABLE BENEFIT-RISK PROFILE IN CURRENT INDICATED PATIENT
POPULATION
    * IN A 14 TO 2 VOTE, ODAC ANSWERED NO TO THE QUESTION: GIVEN
POTENTIAL DETRIMENT IN OVERALL SURVIVAL, FAILURE TO DEMONSTRATE
A PROGRESSION-FREE SURVIVAL BENEFIT, AND LACK OF AN APPROPRIATE
DOSE, IS BENEFIT RISK PROFILE OF MELPHALAN FLUFENAMIDE FAVORABLE
FOR CURRENTLY INDICATED PATIENT POPULATION?

Source text for Eikon:  ID:nWkr7xvwcZ 
Further company coverage:  ONCO.ST 
 (Gdansk Newsroom)
 ((gdansk.newsroom@thomsonreuters.com; +48 58 7696600;))