LONDON (ShareCast) - (Sharecast News) - GSK's Blenrep treatment has been approved by Japanese regulators when in combination for relapsed or refractory multiple myeloma, marking the second major approval of its kind for the drug, with more expected in 2025.
The pharma giant said on Monday that the Ministry of Health, Labour and Welfare in Japan has given the green light for Blenrep combinations, based on positive results from the Dreamm-7 and Dreamm-8 phase III trials.

The trials evaluated Blenrep in combination with bortezomib plus dexamethasone (BVd) and in combination with pomalidomide plus dexamethasone (BPd), respectively, in patients with multiple myeloma who have received at least one prior therapy.

Both trials found statistically significant and clinically meaningful progression-free survival for Blenrep combinations compared with standards of care in both trials, while Dreamm-7 founds improved overall survival rates.

Multiple myeloma patients will often experience relapse and only 43% in Japan will remain alive five years after diagnosis, GSK said.

"Patients need additional treatment options at or after first relapse that can extend remission and survival versus standard of care," said Hesham Abdullah, GSK's senior vice president, global head of oncology, R&D.

"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."

GSK shares were up 0.3% at 1,399p in early deals on Monday.

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