The UK-based pharmaceutical colossus, GSK (LON: GSK, NYSE: GSK), has secured a Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its antibody-drug conjugate, Blenrep (belantamab mafodotin), used in combination with bortezomib and dexamethasone (BorDex). This regulatory milestone for the treatment of relapsed or refractory multiple myeloma (r/r MM) comes on the wings of the Phase III DREAMM-7 trial results, which demonstrated superior progression-free survival and deeper response rates compared to the standard regimen of daratumumab plus BorDex.
Blenrep, developed in collaboration with Seagen Inc. and Kyowa Kirin Group, is an innovative BCMA-targeted therapy. The BTD in China is a testament to the urgent need for new treatment options in the country, where multiple myeloma accounts for approximately 30,000 new cases annually. The DREAMM-7 trial’s interim analysis indicated a noteworthy 24% reduction in the risk of death, with an estimated 19.6% of patients on the Blenrep regimen alive at the five-year mark, outpacing the 9.4% survival rate for those on sorafenib. – Flcube.com
