BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Sinovent Inc.’s EZH2 inhibitor XNW5004 and GlaxoSmithKline’s (GSK) antibody drug conjugate (ADC) belantamab mafodotin are on track to receive breakthrough therapy designations (BTDs).
Sinovent’s XNW5004 is targeting the recurrent or refractory peripheral T-cell lymphoma indication and has demonstrated potential best-in-class efficacy and safety in Phase I clinical trials. This potential breakthrough therapy is expected to offer a new treatment option for patients with this aggressive form of non-Hodgkin’s lymphoma.
On the other hand, GSK’s belantamab mafodotin, a BCMA-targeted ADC, is used in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior treatment. The drug was conditionally approved in the US in 2020 for the treatment of recurrent MM but was withdrawn two years later due to unsuccessful efficacy confirmation in the Phase III DREAMM-3 study. However, the interim analysis of the DREAMM-7 study, revealed in February this year, showed that the belantamab mafodotin/bortezomib/dexamethasone combination significantly prolonged progression-free survival in previously treated MM patients, reigniting interest in its potential.
The CDE’s consideration of these therapies for breakthrough designation reflects China’s commitment to expediting the development and review of new drugs that address unmet medical needs. Both Sinovent and GSK are looking forward to leveraging this designation to expedite their drugs’ path to market, offering hope to patients in need. – Flcube.com
