Posted by Michael Wonder on 18 Nov 2023
Polaris Group initiates rolling submission of biologic license application for ADI-PEG 20 with US FDA to treat malignant pleural mesothelioma
16 November 2023 - Polaris Group today announced that the Company has initiated the rolling submission of its biologic license application for ADI-PEG 20 to the US FDA for the systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology, in combination with a platinum agent and pemetrexed.
This submission is based on the results of the successful Phase 3 trial of ADI-PEG 20 in combination with a platinum agent and pemetrexed which met both its primary and secondary objectives for progression free survival and overall survival.
