The Center for Drug Evaluation (CDE) in China has signaled that Teruisi Pharma’s antibody drug conjugate (ADC), TRS005, which targets CD20, is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory CD20-positive diffuse large B-cell lymphoma (DLBCL). The drug is being developed specifically for patients with DLBCL who have failed at least two standard treatments.
TRS005 has shown promising results in clinical trials, with the potential to surpass existing competitors in terms of both safety and efficacy, as indicated by main efficacy indicators such as objective response rate (ORR) and progression-free survival (PFS). Teruisi Pharma has recently been provided with guidance from the National Medical Products Administration (NMPA) on conducting a pivotal single-arm Phase II clinical trial for TRS005. The CDE has agreed, based on the current safety and efficacy data, to support the conditional approval for market launch of TRS005 through this critical trial.
This development is a significant milestone for Teruisi Pharma, as it moves closer to offering a new treatment option for patients with DLBCL, a type of non-Hodgkin’s lymphoma that can be particularly challenging to treat once it becomes refractory to standard therapies.- Flcube.com
