Oncopeptides has announced its intention to submit a Type II variation application to the European Medicines Agency (EMA) following an "updated assessment of the evolving therapeutic and regulatory landscape in Europe."
The company is seeking to expand the therapeutic indication of Pepaxti (melflufen) to include adult patients with multiple myeloma who have received at least two prior lines of therapies (3L+) and whose disease is refractory to lenalidomide and the last line of therapy.
An approved application for a broader indication (which would include third-line patients) would significantly expand the potential addressable market for Pepaxti.
The company said in its statement that third-line patients are estimated to undergo, on average, twice as many treatment cycles as indicated in the current label, thus potentially doubling the addressable patient population.
Oncopeptides has previously communicated a potential SEK 1.5bn market for Pepaxti in Europe, reflecting the current indication (fourth treatment cycle and onwards).
The company added that the potential regulatory approval, followed by subsequent market access, could unlock significant additional sales potential for Pepaxti in Europe.
"As more drugs have entered the markets across Europe, the treatment landscape has developed and now allows us to pursue an indication in earlier lines of therapy, giving access to a broader population," said Sofia Heigis, CEO of Oncopeptides.
Market experience from the use of Pepaxti has generated positive clinical experience confirming the unmet need for a PDC as a complement to immunotherapy.
Oncopeptides stated that the submission is supported by clinical data from the Phase III study OCEAN. It intends to submit the application during the coming months and expects first regulatory feedback before the end of this year, with a subsequent final decision by the European Commission in H1 2027.