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Home » Telix’s TLX66 Gets Orphan Drug Designation for HSCT Patients
Telix’s TLX66 Gets Orphan Drug Designation for HSCT Patients
March 30, 2022
The FDA has granted Telix Pharmaceuticals an Orphan Drug designation for its monoclonal antibody, TLX66 (90Y-besilesomab), for conditioning treatment of patients prior to undergoing hematopoietic stem cell transplant (HSCT).
In a phase 1/2 clinical trial, all nine participants achieved successful cell transplants following bone marrow conditioning without chemotherapy, the company said. Traditional conditioning regimens that use chemotherapy are limited in their use because of the side effects, especially for pediatric and rare diseases.
TLX66’s potential to reduce the toxicity of existing conditioning regimens could increase the number of patients who are eligible for transplants, Telix said.
The antibody was previously granted Orphan Drug status by the European Medicines Agency, but has not yet received a marketing authorization in Europe.
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