Oncopeptides to Apply for Accelerated Approval in the US
Stockholm – May 20, 2019 - Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today that, after discussions with the FDA, the company has initiated the preparation for submitting a New Drug Application (NDA) for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma. The company targets to submit the application in the first quarter of 2020.During the spring, Oncopeptides has been engaged in dialogue with the FDA to explore whether melflufen could be eligible for accelerated approval based on the promising data generated in the ongoing