Posted by Michael Wonder on 26 Jun 2022
CHMP issues a positive opinion recommending full approval of Oncopeptides Pepaxti in EU for patients with triple class refractory multiple myeloma
23 June 2022 - Oncopeptides today announces that the EMA's CHMP, has unanimously adopted a positive opinion recommending a full marketing authorisation approval of Pepaxti (melphalan flufenamide) in EU.
The positive opinion is based on data from the phase 2 HORIZON study and is supported by data from the randomised controlled phase 3 OCEAN study which was utilised as confirmatory study.
