USFDA extends review period for GSK Blenrep in relapsed/refractory multiple myeloma

Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

"GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review," the company stated.

Blenrep combinations are currently approved in the UK, Japan, Canada, Switzerland (DREAMM-8 only at this time) and the United Arab Emirates. Applications are currently under review in all major markets globally, including the EU and China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).

Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.