The company has announced that the last patient has been included in the OP-106 HORIZON phase 2 clinical study evaluating melflufen with dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM).
Oncopeptides has previously communicated a target enrollment of 150 patients in the study before the end of September, which now has been achieved.
Could potentially lead to the first market approval for melflufen in the U.S. in 2020
Oncopeptides is engaged in preparations for submitting a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for accelerated market approval in the United States based on available data from the HORIZON study. The objective is to submit the application in the first quarter of 2020. This could then potentially lead to the first market approval for melflufen in the U.S. in 2020.
“The HORIZON study was initially intended as an exploratory study in late-stage patients with relapsed and/or refractory multiple myeloma when started in January 2017. As positive efficacy and safety data were generated, the study was expanded to include 150 patients and now forms the basis of our planned application for accelerated market approval in the United States. We are encouraged that the data to-date support the potential for melflufen to offer a new treatment option in this important setting, especially for patients with severe and widespread multiple myeloma. This is an important milestone in Oncopeptides’ history and signifies that we are on track for submitting our NDA in the U.S. as planned, which will completely transform the company if approved,” says Jakob Lindberg, CEO of Oncopeptides.
Photo of Jakob Lindberg: Oncopeptides