Polaris Group’s Biologic License Application (BLA) for Pegargiminase (ADI-PEG 20) has officially entered the FDA substantive review stage.
2025/8/18-Polaris Group (The Company, TWSE:6550) previously adopted a rolling submission approach for regulatory filing of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA) on November 16, 2023 (U.S. time). ADI-PEG 20 is the systemic treatment of patients with Malignant Pleural Mesothelioma (MPM) with non-epithelioid histology, in combination with a platinum agent and pemetrexed. The final portion of the BLA submission was completed on June 9, 2025 (U.S. time).