Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Aug 4
- 1 min read
03/08/2026
US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer (Ref)
Eli Lilly announced that the US FDA has granted Breakthrough Therapy designation to olomorasib (KRAS G12C inhibitor) as monotherapy for KRAS G12C-mutant advanced pancreatic cancer in patients previously treated with systemic therapy
Designation is supported by preliminary results from the Phase 1/2 LOXO-RAS-20001 trial (NCT04956640), evaluating safety, tolerability, and efficacy in KRAS G12C-mutant advanced solid tumors including pancreatic cancer who have received at least one prior systemic therapy
FDA Grants Orphan Drug Designation to DLL3-Targeting ADC Zoci, for Neuroendocrine Carcinomas (Ref)
Zai Lab announced that the US FDA has granted Orphan Drug Designation (ODD) to its DLL3-targeting antibody-drug conjugate zocilurtatug pelitecan (Zoci) for the treatment of neuroendocrine carcinomas (NECs)
Zoci has also received ODD from the EMA for pulmonary NECs, and the FDA previously granted Fast Track Designation and ODD for small cell lung cancer (SCLC) and extrapulmonary NECs
Zoci is advancing toward three registration-enabling studies by end of 2026, covering second-/third-line SCLC, first-line SCLC, and extrapulmonary NECs
Comments