- GSK
- 13 September 2024 07:38:45
Source: Sharecast
The award was based on results from GSK's phase III DREAMM-7 phase III clinical trial which evaluated Blenrep combined with BorDex for the treatment of relapsed or refractory multiple myeloma, a type of bone marrow cancer.
Positive overall survival trends were observed, though they were not statistically significant at the time of interim analysis. However, results showed clinically meaningful improvements across all other secondary efficacy endpoints, GSK said.
According to the World Health Organization, multiple myeloma affects 30,000 new people each year in China, while incidence rates have doubled and mortality has increased 1.5-fold over the past three decades.
BTD grants from the National Medical Products Administration are intended to expedite the development of therapies for serious and life-threatening diseases for which there are no existing treatments, or where clinical trials show an improvement in patient outcomes over what's available on the market.
“Breakthrough Therapy Designation in China underscores the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after their first relapse," said Hesham Abdullah, senior vice president and global head of oncology at GSK's R&D division.
"We look forward to continuing to work with the health authority in China and others worldwide to bring Blenrep-based combinations to patients as expeditiously as possible.”