2025/6/9
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).
The final portion of the BLA submission includes the Chemistry, Manufacturing, and Controls (CMC) section. The U.S. FDA will respond within 60 days of receiving the BLA. The actual review timeline and approval status will be subject to official notification from the U.S. FDA.
About Malignant Pleural Mesothelioma (MPM)
MPM is a highly aggressive and challenging cancer that affects the lining of the lungs. It is primarily caused by asbestos exposure and is characterized by poor prognosis and limited treatment options. Current treatments mainly include chemotherapy and immunotherapy.
ADI-PEG 20 is a novel therapy that holds promise in the treatment of malignant pleural mesothelioma, a rare and aggressive form of cancer. The Company’s development program for ADI-PEG 20 is focused on demonstrating its safety and efficacy in addressing the pressing medical needs of patients facing this challenging condition.