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Fda Breakthrough Therapy

All articles tagged with #fda breakthrough therapy

KRAS-Targeting Drug daraxonrasib Delivers Major Survival Gain in Pancreatic Cancer
health1 month ago

KRAS-Targeting Drug daraxonrasib Delivers Major Survival Gain in Pancreatic Cancer

A phase trial found daraxonrasib, a pan-RAS inhibitor that targets KRAS, nearly doubles survival for patients with advanced pancreatic cancer (median ~15 months vs historically under 8). The FDA granted Breakthrough Therapy and Orphan Drug designations and expanded-access use ahead of potential full approval later in 2026. While not a cure, the drug offers meaningful survival benefit with manageable side effects, and researchers are exploring combination therapies and immunotherapy approaches.

FDA Grants Breakthrough Status to Raludotatug Deruxtecan for CDH6-Expressing Ovarian and Gynecologic Cancers
healthcare9 months ago

FDA Grants Breakthrough Status to Raludotatug Deruxtecan for CDH6-Expressing Ovarian and Gynecologic Cancers

Raludotatug deruxtecan has received FDA Breakthrough Therapy Designation for treating CDH6-expressing platinum-resistant ovarian, peritoneal, or fallopian tube cancers, based on promising early trial data, marking a significant step in developing new treatments for these difficult-to-treat cancers.