Polaris Submits Application for New Mesothelioma Treatment

Multinational biopharmaceutical company Polaris Group announced their application for a rolling submission of a new mesothelioma treatment this month. The Biologic License Application for the experimental drug ADI-PEG 20 is the first step in U.S. Food and Drug Administration approval.  The application outlines the use of ADI-PEG 20 for non-epithelioid mesothelioma alongside treatment with pemetrexed and platinum chemotherapy. Non-epithelioid subtypes include sarcomatoid and biphasic cell types, historically the most resistant to treatment.  Polaris stated in a press release, “Polaris Group’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. Three Phase 3 clinical studies with ADI-PEG 20 in other hard-to-treat cancers are currently ongoing.”  Biologic License Application Could Hasten FDA Approval Polaris’s BLA submission follows a successful phase 3 clinical trial that met its progression-free and overall survival goals. Rolling submission allows for a streamlined approach to the regulatory review process, which could reduce the time until the drug’s approval. The company will finalize the remaining chemistry, manufacturing and controls in the coming months.  “Pegargiminase [ADI-PEG 20] is designed to disrupt cancer cell metabolism, providing a novel approach to treating a wide range of cancers heavily influence...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Tags: Clinical Trials/Research/Emerging Treatments Mesothelioma Source Type: news