Fubotv earnings beat by $0.10, revenue topped estimates
Investing.com -- GSK (LON:GSK) shares dropped more than 6% on Friday after a U.S. Food and Drug Administration advisory panel voted against the benefit-risk profile of Blenrep (belantamab mafodotin-blmf) combinations for treating relapsed or refractory multiple myeloma.
The Oncologic Drugs Advisory Committee reviewed the treatment in adults who had received at least one prior line of therapy and concluded that the benefits of the proposed dosing regimen did not outweigh the risks.
The FDA will consider the panel’s non-binding recommendation as it continues its review, with a decision due by the July 23, PDUFA date.
GSK said it will continue to work with the agency during the ongoing review process. The company noted that Blenrep combinations are already approved in several countries, including the UK, Japan, and Switzerland.
Those approvals are based on results from the DREAMM-8 trial. Applications are also under review in other markets, including the European Union and China, supported by data from the DREAMM-7 trial.
The U.S. FDA has granted the combination Breakthrough Therapy Designation and is conducting a priority review.
Multiple myeloma is the third most common blood cancer globally, with more than 180,000 new cases diagnosed each year, according to GSK.
In the U.S., over 35,000 cases were reported in 2024. The disease is considered treatable but not curable and often becomes resistant to existing therapies.
GSK said many patients receive treatment outside academic centers, underscoring the need for new therapies that can be administered in community settings.
Blenrep is an antibody-drug conjugate designed to deliver chemotherapy directly to cancer cells. It consists of a monoclonal antibody that targets the
BCMA protein on myeloma cells, linked to the cytotoxic agent auristatin F. The drug linker technology is licensed from Seagen Inc., and the antibody is produced using POTELLIGENT Technology from BioWa Inc., part of the Kyowa Kirin Group.
In the UK, Blenrep is indicated for use in adults with multiple myeloma in two specific combinations. It is approved for use with bortezomib and dexamethasone in patients who have received at least one prior therapy, and with pomalidomide and dexamethasone in those previously treated with lenalidomide.
The FDA’s final decision on the drug’s U.S. application is expected by the end of the month.