Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis
The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.
- The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy.
- “Approximately 42,000 patients with HNC undergo standard-of-care radiotherapy every year in the U.S. and are at risk of developing SOM.
- Meaningful reduction in the number of patients who developed the most severe form of SOM (Grade 4) was also observed.
- Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem, or GC4419) is being evaluated for radiotherapy-induced toxicities.