Oncopeptides has been granted a priority review by the U.S. Food and Drug Administration, for the New Drug Application of melflufen in combination with dexamethasone for the treatment of adult patients with multiple myeloma.
The patients have a disease that is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, i.e., triple-class refractory multiple myeloma patients. The FDA has set a PDUFA-date, a target date for their review, to February 28, 2021.
Following a potential approval by the FDA, our strategy is to commercialize melflufen in the US with our own organization. Based on the outcomes of the phase 3 OCEAN study we may submit a supplementary New Drug Application, to broaden the indication of melflufen. Our intention is to develop melflufen as a backbone in the treatment of relapsed, refractory multiple myeloma.
Increasing geographical footprint
In the second quarter of 2021, Oncopeptides will submit melflufen to the European Medicines Agency for a potential conditional marketing authorization. During 2021 we will further strengthen our presence in Europe and develop a dedicated medical affairs and commercial organization that can pave the way for a commercial launch. Also, in Europe, our intention is to launch melflufen with our own commercial organization.
While our primary focus is to further expand the organization in the U.S. and Europe to fully support the commercial launch of melflufen, and optimize patient access, we will also explore options to broaden our geographical footprint, through commercial partnerships.
Leveraging technology platform
In 2021 we will initiate a clinical development program for the second drug candidate coming out of our PDC platform, OPD5. OPD5 can be administered in high doses, which provide a rationale for developing the drug as a potential myeloablative treatment followed by Autologous Stem Cell Transplantation in patients with relapsed refractory multiple myeloma.
The new drug development facility in Solna, Sweden will enable us to further expand the development of our PDC platform and generate new drug candidates for other hematological indications where there is a significant unmet medical need.