Polaris Group (TPE:6550) said the U.S. Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for pegargiminase (ADI-PEG 20), moving the cancer therapy into substantive review, according to a Tuesday filing on the Vietnam Stock Exchange.

The submission covers the use of ADI-PEG 20 for patients with malignant pleural mesothelioma with non-epithelioid histology, in combination with a platinum agent and pemetrexed.

The final portion of the rolling BLA was filed on June 9. Polaris held an orientation meeting with nearly 120 FDA reviewers in early August to address questions on the filing.