Polaris Group announced that the Company has initiated the rolling submission of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology, in combination with a platinum agent and pemetrexed. This submission is based on the results of the successful phase 3 trial of ADI-PEG 20 in combination with a platinum agents and pemetrexed which met both its primary and secondary objectives for progression free survival and overall survival. The rolling submission process allows for the submission of individual modules of the BLA as they are completed, which can streamline the regulatory review process and may expedite the potential approval timeline.

This initial submission to the U.S. FDA includes the nonclinical and clinical portions of the BLA for ADI-PEG20, with plans to finalize the remaining chemistry, manufacturing, and controls components in the coming months. When the final portion of the BLA is submitted, Polaris Group will actively seek priority review status for this BLA, which, if granted, could expedite the regulatory review process.