FDA granted Breakthrough Therapy Designation and Orphan Drug Designation for D3S-001 for Patients with KRAS G12C-Mutated Cancers
“We are very pleased to receive both Breakthrough Therapy and Orphan Drug Designations from the FDA for D3S-001, which highlights D3S-001’s promising potential to address critical unmet needs in patients with KRAS G12C-mutated cancers,” said George Chen, Founder and CEO of D3 Bio. “These designations also recognize D3S-001’s novel profile as a next-generation KRAS G12C inhibitor. We look forward to bringing this exciting new treatment to patients with support and collaboration from health authorities.”
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