GSK’s Blenrep Combinations Approved in Japan for Relapsed or Refractory Multiple Myeloma

GSK’s Blenrep combinations have been approved in Japan for treating relapsed or refractory multiple myeloma, following strong Phase III trial results demonstrating improved survival outcomes.

Japan’s Ministry of Health, Labour and Welfare (MHLW) approved GSK‘s Blenrep (belantamab mafodotin) combinations as therapy for adult patients with relapsed or refractory multiple myeloma. This key regulatory breakthrough is based on strong positive results from the Phase III DREAMM-7 and DREAMM-8 trials.

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The combinations approved are Blenrep with bortezomib and dexamethasone (BVd) and pomalidomide and dexamethasone (BPd). These combinations were tested in patients exposed to at least one prior multiple myeloma therapy.

Today’s approval brings the benefits of Blenrep combinations to patients with relapsed or refractory multiple myeloma in Japan. Patients need additional treatment options at or after first relapse that can extend remission and survival versus standard of care. Blenrep combinations have the potential to redefine treatment outcomes based on superior efficacy shown in two phase III trials, with the added advantage of in-office administration in both academic and community treatment settings.

Hesham Abdullah

Both the DREAMM-7 and DREAMM-8 trials highlighted greater efficacy for the Blenrep combinations compared to existing standards of care. Importantly, the trials showed statistically significant and clinically relevant gains in progression-free survival (PFS). Additionally, the DREAMM-7 trial also showed an overall survival (OS) benefit. The safety and tolerability profiles seen in these trials were in line with known profiles of the individual agents within the combinations.

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Blenrep is the only anti-BCMA antibody-drug conjugate (ADC) available on the market for the treatment of multiple myeloma, with a unique mechanism of action against the disease. One of the benefits of such combinations of Blenrep is the ease of administration, which can be done in different oncology treatment environments without the need for complicated pre-administration steps or hospitalization.

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Blenrep

Blenrep is an antibody-drug conjugate (ADC) that combines a humanized BCMA-targeting monoclonal antibody with the cytotoxic agent auristatin F, connected through a non-cleavable linker. The linker technology is licensed from Seagen Inc., while the monoclonal antibody is developed using POTELLIGENT® Technology, licensed from BioWa Inc., part of the Kyowa Kirin Group.


Source: GSK

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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.

Ajmal Aseem

Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.

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