Plus Therapeutics received Orphan Drug Designation from the FDA for its Rhenium (¹⁸⁶Re) Obisbemeda, a treatment for leptomeningeal metastases (LM) in lung cancer patients. This designation follows the successful completion of the Phase 1 single-dose trial, which identified the recommended Phase 2 dose. The company is also pursuing a Fast Track designation for the drug.
This FDA decision is crucial for patients with LM originating from lung cancer, a debilitating condition with limited effective treatments and a dismal prognosis. The Orphan Drug Designation underscores the unmet medical need and incentivizes further development of Rhenium (¹⁸⁶Re) Obisbemeda, potentially providing a life-extending treatment option for these patients. Furthermore, the increasing incidence of LM makes the development of targeted therapies even more critical.
The Orphan Drug Designation provides Plus Therapeutics with seven years of market exclusivity if the drug is approved, as well as tax credits for clinical trials and exemptions from certain FDA fees. The company is now initiating a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial. Plus Therapeutics is actively working with the FDA to finalize the pivotal trial strategy.
This designation significantly de-risks the development of Rhenium (¹⁸⁶Re) Obisbemeda and strengthens its market potential. Coupled with the ongoing clinical trials and collaboration with the FDA, this positions Plus Therapeutics to potentially bring a much-needed therapy to patients battling this devastating complication of lung cancer. It also solidifies the company’s position in the targeted radiotherapeutics market, particularly for central nervous system cancers. The next stage of clinical development will be critical in confirming the drug’s efficacy and safety profile, paving the way for potential regulatory approval and ultimately, improved outcomes for patients with LM.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
