Onco-Summaries: Daily Oncology Updates at a Glance

15/04/2026

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• FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma

• FDA Grants Fast Track to Opna Bio’s OPN-6602 for Relapsed/Refractory Multiple Myeloma

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FDA Grants Orphan Drug Status to Immutep’s Eftilagimod Alfa in Soft Tissue Sarcoma (Ref)

Immutep’s lead candidate, eftilagimod alfa (efti), has received Orphan Drug Designation from the U.S. FDA for soft tissue sarcoma (STS), a rare cancer with high unmet need

• Supporting clinical data:

  
  

  • Based on results from the Phase II EFTISARC-NEO trial combining efti with radiotherapy and pembrolizumab (KEYTRUDA®) in the neoadjuvant setting in patients with resectable soft tissue sarcoma

  
  

  • In 38 evaluable patients, the trial met its primary endpoint with median tumor hyalinization/fibrosis of 51.5%, surpassing the target of 35% and historical ~15% with radiotherapy alone

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FDA Grants Fast Track to Opna Bio’s OPN-6602 for Relapsed/Refractory Multiple Myeloma (Ref)

The FDA has granted Fast Track status to OPN-6602, Opna Bio’s dual EP300/CBP inhibitor, for treating relapsed/refractory multiple myeloma in patients who have undergone at least four prior lines of therapy

• OPN-6602 is in a Phase 1 trial, assessing safety, tolerability, pharmacokinetics, and early clinical activity

  
  

• PN-6602 had already received Orphan Drug Designation in January 2025

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