BRIEF—Oncopeptides to submit Accelerated Approval application in USA

Sweden’s Oncopeptides will apply for accelerated approval in the USA for melflufen, as a therapy for people with triple-class refractory multiple myeloma, at the start of 2020.

During the spring, the firm has been discussing with the regulator the possibility of using its Phase II HORIZON trial data to support an application.

Chief executive Jakob Lindberg said: "The outcome of the regulatory discussions during the spring is even better than we anticipated and is a major milestone for Oncopeptides as it means that we can start the application process and potentially attain market approval significantly earlier than planned.”

The firm will present updated HORIZON data at the European Hematology Association (EHA) meeting in Amsterdam on June 16.