LM ODD for Lung Cancer Patients

by | Mar 6, 2025 | LM

FDA Grants Orphan Drug Designation to Rhenium (186Re) Obisbemeda for Lung Cancer Patients with Leptomeningeal Metastases

We are thrilled to announce that the U.S. FDA has granted Orphan Drug Designation (ODD) to Rhenium (186Re) Obisbemeda for the treatment of leptomeningeal metastases (LM) in lung cancer patients. This designation underscores the urgent need for innovative therapies for LM, a devastating complication of metastatic cancer.

This achievement follows the successful completion of the ReSPECT-LM Phase 1 single-dose trial, which established the recommended Phase 2 dose (RP2D). As we move forward, Plus Therapeutics is advancing a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial, working closely with the FDA to refine the pivotal trial strategy.

What This Means for Patients & Research

  • Provides regulatory support & incentives to accelerate drug development
  • Highlights the potential of targeted radiotherapeutics in treating LM
  • Brings us one step closer to new treatment options for patients facing this aggressive disease

For full details, read the official press release:
👉 Press Release

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