Onco-Summaries: Daily Oncology Updates at a Glance

19/05/2026

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• Cullinan’s CLN‑049 earns FDA Orphan Drug Designation in relapsed/refractory AML

• FL118 Receives Dual FDA Designations for Osteosarcoma, Advancing Rare Pediatric Cancer Treatment

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Cullinan’s CLN‑049 earns FDA Orphan Drug Designation in relapsed/refractory AML (Ref)

LN-049, a novel FLT3 x CD3 T cell engager, has received Orphan Drug Designation for relapsed/refractory acute myeloid leukemia (AML)

CLN-049 is in Phase 1 trials, including multiple ascending dose studies in relapsed/refractory AML and myelodysplastic syndrome (MDS), as well as for the treatment of patients with AML with measurable residual disease (MRD)

CLN-049 has also received Fast Track designation from the FDA for the treatment of relapsed/refractory AML

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FL118 Receives Dual FDA Designations for Osteosarcoma, Advancing Rare Pediatric Cancer Treatment (Ref)

The FDA has granted both Rare Pediatric Disease Designation and Orphan Drug Designation to FL118, a novel anticancer compound discovered at Roswell Park Comprehensive Cancer Center, for the treatment of osteosarcoma

• These designations were awarded to Canget BioTekpharma LLC, a Roswell Park spinoff, and strengthen the drug's development position for rare and difficult-to-treat cancers.

• FL118 already holds FDA Orphan Drug Designation for pancreatic cancer — the new osteosarcoma designations further broaden its regulatory foundation

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