-- GSK (GSK.L) received approval from China's National Medical Products Administration for Blenrep, providing a new treatment option for patients with relapsed or refractory multiple myeloma amid the continued rise in cases in the country.
In a Monday filing, the biopharma company noted that China's multiple myeloma cases have doubled to 30,000 annually, with mortality rising 50% over three decades. Globally, the "treatable but incurable" disease is considered the third most common blood cancer, with 180,000 new cases diagnosed yearly.
Following a priority review by the Chinese regulator, the monoclonal antibody-drug conjugate was cleared for use in combination with bortezomib and dexamethasone to treat adult patients who have undergone at least one prior line of therapy.
The approval was backed by data from the Dreamm-7 phase 3 study, with the Blenrep regimen delivering "statistically significant and clinically meaningful" progression-free survival and overall survival results against the daratumumab-based triplet combination with bortezomib and dexamethasone. Additionally, the Blenrep combination maintained a consistent safety profile with the documented safety characteristics of the individual medications involved.
"Today's approval of Blenrep brings anti-[B-cell maturation antigen] therapy to patients in China with relapsed or refractory multiple myeloma in 2L+, introducing a differentiated mechanism of action with the potential to help slow disease progression and extend survival. Further, Blenrep, as the only anti-BCMA ADC, is fully outpatient administered, so patients can be treated at any site of care without complex pre-administration regimens or hospitalisation," said Hesham Abdullah, senior vice president, global head oncology, research & development at GSK.
With more than 15 authorizations internationally, Blenrep is an established treatment for second-line plus multiple myeloma across markets, including the European Union, the UK, and Japan. The approved combinations include dexamethasone and either bortezomib or pomalidomide.
GSK's London-listed stock was marginally down by Monday midday trade.