19th May 2025 08:20
(Alliance News) - GSK PLC on Monday said it has received approval in Japan for Blenrep combinations in the treatment of adults with relapsed or refractory multiple myeloma.
The London-based pharmaceutical company said the approval by Japan's Ministry of Health, Labour & Welfare was based on positive results from the Dreamm-7 and Dreamm-8 phase 3 trials evaluating Belnrep in combination with bortezomib plus dexamethasone, and in combination with pomalidomide plus dexamethasone.
Trials demonstrated statistically significant and clinically meaningful progression-free survival results for Blenrep combinations compared to current standards of care.
This follows Blenrep's receipt of an orphan drug designation in Japan, which was granted based on its ability to address high unmet need for patients with multiple myeloma who have received at least one prior therapy.
Most patients with multiple myeloma experience relapse, and in Japan only around 43% remain alive five years after diagnosis.
"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," says Hesham Abdullah, senior Vice President, Global Head Oncology, R&D, GSK,
"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."
This was the second major regulatory approval for Blenrep combinations for the treatment of relapsed or refractory multiple myeloma, following its approval in April by the UK Medicines & Healthcare products Regulatory Agency.
Blenrep combinations are currently under review in "all major markets globally", GSK said, including in the US with a prescription drug user fee act date of July 23, as well as the EU, China, Canada and Switzerland.
Shares in GSK were flat at 1,394.50 pence in London on Monday morning. The stock is down 21% over the past year.
By Emily Parsons, Alliance News reporter
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