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).
According to the FDA’s letter dated June 26, 2025, the Company was scheduled to hold an Applicant Orientation Presentation Meeting (AOM – a post-submission briefing) on the evening of August 1, 2025, Taiwan time (morning of August 1, U.S. time). During this meeting, the Company delivered an oral presentation via video conference to nearly 120 FDA reviewers and responded to their questions. The meeting was successfully completed as planned.
The Company just received the FDA letter with the following excerpt:
”Please refer to your biologics license application (BLA) dated June 9, 2025, and your amendments, under section 351(a) of the Public Health Service Act for ADI-PEG 20. We also refer to your presubmissions dated November 16, 2023, and May 16, 2025. We have completed our filing review and have determined that your application is sufficiently complete to permit a substantive review.” Based on the contents of this letter, the application has officially entered the substantive review stage.
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.