Pharmaceutical company Oncopeptides AB (Nasdaq Stockholm:ONCO) said on Monday that it has initiated the preparation for submitting a New Drug Application (NDA) for accelerated approval of melflufen with the US FDA for the treatment of patients with triple-class refractory multiple myeloma .

Based on the promising data generated in the ongoing phase 2 HORIZON clinical trial, the company aims to submit the NDA application of melflufen with the US FDA in the first quarter of 2020 as well as expects the first melflufen market approval in the US in 2020. The FDA has received all available clinical data at hand for melflufen.

According to the company, Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class of Peptidase Enhanced Cytotoxics (PEnC) and have the potential to treat many cancers.

The US FDA will review whether melflufen could be eligible for accelerated approval for the treatment of patients with relapsed refractory multiple myeloma whose disease is triple-class refractory (i.e. refractory to at least one IMiD, one proteasome inhibitor and one anti-CD38 monoclonal antibody), added the company.

Additionally, the company will host a conference call and present an operational update on 21 May 2019 at 10:00 (CET). It will be presented by CEO Jakob Lindberg and members of the management team. The conference call will be streamed via a link on the website: http://www.oncopeptides.com.