Home » Galera Nabs FDA Fast Track for GC4419
Galera Nabs FDA Fast Track for GC4419
The FDA has awarded Galera Therapeutics fast track designation for GC4419, a candidate that aims to reduce the severity and incidence of oral mucositis caused by radiation and chemotherapy.
Galera has begun enrollment in a Phase 2b study for head and neck cancer patients that will investigate the ability of 30- and 90-mg doses administered before radiation therapy. The study is expected to enroll 200 patients at roughly 55 sites in the U.S.
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