> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Galera Gets ‘Complete Response’ on Mucositis Drug
- URL: https://www.fdaweb.com/galera-gets-complete-response-on-mucositis-drug/
- Published: 2023-08-09T12:00:00.000Z
- Updated: 2026-09-14T18:49:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155066

FDA has issued Galera Therapeutics a complete response letter (CRL) on an NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. “In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer,” Galera says, adding that its NDA included data from a total of 678 patients enrolled in two randomized, double-blind, placebo-controlled trials (Phase 3 ROMAN and Phase 2b GT-201).

According to the company, the CRL said that data from an additional clinical trial will be required to resubmit the NDA. Galera says it is requesting a Type A meeting with the agency to understand its decision and discuss next steps to support resubmission.

Meanwhile, Galera says it is restructuring its operations and reducing headcount to focus resources on avasopasem and ongoing clinical trials for rucosopasem, the company’s other product candidate in development for “anti-cancer efficacy of stereotactic body radiation therapy (SBRT) for patients with non-small cell lung cancer and locally advanced pancreatic cancer… “Our GRECO-2 trial is a 220-patient trial in locally advanced pancreatic cancer intended to build upon the positive results observed in our placebo-controlled pilot trial, where we saw meaningful improvements in multiple endpoints including overall survival and tumor outcomes. There is an urgent need for novel therapies to extend survival in patients with pancreatic cancer, and we believe rucosopasem’s unique mechanism of action in combination with SBRT could offer a transformative treatment option.”