Pharma Focus Asia

Galera Therapeutics Announces FDA Orphan Drug Designation for Rucosopasem

Friday, May 19, 2023

Galera Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Galera’s second product candidate, rucosopasem manganese (rucosopasem), for the treatment of pancreatic cancer.

Rucosopasem is a next-generation selective dismutase mimetic in clinical development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with pancreatic cancer and lung cancer.

Orphan drug designation for rucosopasem highlights the urgent need for more treatment options to extend survival in patients with pancreatic cancer, which is the fourth leading cause of cancer death in the U.S. It is believed that rucosopasem has the potential to improve the efficacy of SBRT for pancreatic cancer.

The Company is currently conducting the GRECO-2 Phase 2b randomised, double-blind, placebo-controlled 220-patient trial of rucosopasem in combination with SBRT in patients with locally advanced pancreatic cancer (LAPC).

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