GSK's Granted Blenrep Combination Therapy for Relapsed/Refractory Multiple Myeloma
Monday, December 09, 2024
GSK has announced that China’s National Medical Products Administration (NMPA) has accepted a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for the treatment of relapsed or refractory multiple myeloma.
Multiple myeloma is the third most common blood cancer globally and remains treatable but not curable. With over 180,000 new cases diagnosed worldwide each year, it continues to pose significant challenges. In China, the disease is a growing concern, with approximately 30,000 new cases annually.
The incidence and mortality rates of multiple myeloma in the country have risen significantly over the past three decades, underscoring the need for innovative treatment options.
Earlier this year, the BVd combination received both priority review and Breakthrough Therapy Designation, aimed at accelerating the development of promising treatments that could significantly improve patient outcomes.
The submission is supported by interim findings from the DREAMM-7 Phase III trial. This trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for BVd when compared to the combination of daratumumab, bortezomib, and dexamethasone (DVd).
In a subsequent analysis, BVd also showed improved overall survival (OS), reducing the risk of death compared to the standard of care.
This is the seventh major regulatory submission this year for belantamab mafodotin in combination therapy for relapsed or refractory multiple myeloma. Similar applications have been submitted in the United States, European Union, Japan (also under priority review), United Kingdom, Canada, and Switzerland.
The DREAMM-7 trial results offer hope for a potential new standard of care in treating this challenging condition, especially for patients who relapse or develop resistance to existing therapies.
Source: gsk.com
