GSK plc (LSE:GSK) has won regulatory approval in China for Blenrep in combination with bortezomib and dexamethasone (BVd) to treat adults with relapsed or refractory multiple myeloma who have had at least one prior line of therapy. The approval followed a priority review and Breakthrough Therapy Designation.
The decision rests on DREAMM‑7, a 494‑patient, randomised phase III trial in which BVd extended median progression‑free survival to 36.6 months versus 13.4 months for DVd (HR 0.41; p<0.00001) and cut the risk of death by 42% at a median follow‑up of 39.4 months (HR 0.58). Three‑year overall survival was 74% with BVd versus 60% with DVd.
Blenrep is now the only anti‑BCMA therapy authorised in China for 2L+ myeloma and is the only anti‑BCMA antibody‑drug conjugate delivered fully in outpatient settings. DREAMM‑7 reported manageable, reversible eye‑related events with low discontinuation rates (≤9%); the most common non‑ocular adverse events in the BVd arm were thrombocytopenia (87%) and diarrhoea (32%).
"Patients with multiple myeloma who face relapse need treatment options that are both effective and accessible. Today's approval of Blenrep brings anti‑BCMA therapy to patients in China with relapsed or refractory multiple myeloma in 2L+, introducing a differentiated mechanism of action with the potential to help slow disease progression and extend survival. Further, Blenrep as the only anti‑BCMA ADC is fully outpatient administered, so patients can be treated at any site of care without complex pre‑administration regimens or hospitalisation." — Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK (LSE:GSK).
