Friday, November 17, 2023
Polaris Group, listed as TWSE:6550, has announced the initiation of the rolling submission of its Biologic License Application (BLA) for ADI-PEG 20 to the U.S. Food and Drug Administration (FDA). This submission aims to seek approval for the systemic treatment of patients with malignant pleural mesothelioma featuring non-epithelioid histology, in combination with a platinum agent and pemetrexed.
The decision to pursue a rolling submission follows the positive outcomes of the phase 3 trial of ADI-PEG 20, meeting both primary and secondary objectives related to progression-free survival and overall survival. The rolling submission approach allows the company to submit completed modules of the BLA progressively, potentially expediting the regulatory review process and approval timeline.
The initial submission covers the nonclinical and clinical components of the BLA for ADI-PEG 20, with plans to finalize the remaining chemistry, manufacturing, and controls components in the coming months. Polaris Group aims to actively seek priority review status for the BLA upon the final submission, a designation that, if granted, could further accelerate the regulatory review process.
Polaris Group, emphasized the promising results from clinical trials, indicating the potential of ADI-PEG 20 to address the medical needs of patients with malignant pleural mesothelioma. The comprehensive development program is designed to furnish robust data supporting the FDA's review.
Polaris Group, expressed the company's dedication to addressing the urgent medical needs of patients with malignant pleural mesothelioma. The submission represents a significant step toward expanding treatment options for affected patients in the U.S. If approved, ADI-PEG 20 could contribute to addressing hard-to-treat cancers.
ADI-PEG 20 is a novel therapy showing promise in treating malignant pleural mesothelioma, a rare and aggressive cancer primarily caused by asbestos exposure. Polaris Group's development program is focused on demonstrating its safety and efficacy in addressing the challenging medical needs of patients facing this condition. Additionally, three Phase 3 clinical studies with ADI-PEG 20 in other hard-to-treat cancers are currently underway.
Malignant pleural mesothelioma is a highly aggressive cancer affecting the lining of the lungs, primarily caused by exposure to asbestos. It is associated with poor prognosis and limited treatment options.