Telix’s TLX66 Gets Orphan Drug Designation for HSCT PatientsTelix’s TLX66 Gets Orphan Drug Designation for HSCT Patients
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.
Telix is a late-stage radiopharmaceutical company developing a broad portfolio of diagnostic and therapeutic (‘theranostic’) assets using Molecularly Targeted Radiation (MTR). Telix’s research pipeline aims to address significant unmet medical need in prostate, kidney, brain (glioblastoma), and hematologic cancers as well as a range of immunologic and rare diseases. Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States.
March 30, 2022
