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.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial