Blenrep Approved Europe: Multiple Myeloma Treatment
The EMA panel greenlights Blenrep for multiple myeloma treatment, signaling a potential breakthrough for patients facing relapsed or refractory forms of this challenging cancer. This positive opinion elevates the antibody-drug conjugate, Blenrep, developed by GSK. It gives those facing this rare disease renewed hope by targeting the B-cell maturation antigen (BCMA). News Directory 3 reports that this innovative approach marks a significant advancement compared to existing therapies. However, the EMAS decision highlights the need for vigilant monitoring due to potential ocular side effects. Discover what’s next as the Summary of Product Characteristics on the EMA website clarifies Blenrep’s role and the management of side effects within the broader landscape of multiple myeloma treatment options.
Blenrep’s Role in Treating Multiple Myeloma Receives positive Opinion
Updated May 26, 2025
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding Blenrep (Mafodotin Belantamab) for treating relapsed or refractory multiple myeloma. This recommendation highlights Blenrep’s potential role in addressing this challenging cancer.
Blenrep,developed by GSK,is an antibody-drug conjugate. It targets the B-cell maturation antigen (BCMA) found on myeloma cells. Once Blenrep binds to BCMA, it halts cell cycle progression and triggers antibody-dependent cellular cytotoxicity. GSK reports that Blenrep is the first conjugate of it’s kind approved, offering a new mechanism of action compared to existing treatments.
Multiple myeloma,a rare and currently incurable plasma cell disease,primarily affects adults over 60. Initial treatment often involves targeted drugs like lenalidomide or bortezomib, combined with steroids, and sometimes chemotherapy and stem cell transplants. relapses are typically managed similarly.The CHMP noted the need for effective therapies, given the disease’s generally poor prognosis. Blenrep previously received orphan medicine designation, which the EMA will now re-evaluate.
Two Phase 3 trials indicated that adding Blenrep to standard therapies prolonged progression-free survival in patients with relapsed or refractory multiple myeloma. These therapies included either bortezomib and dexamethasone (for patients with at least one prior therapy) or pomalidomide and dexamethasone (for patients with at least one prior therapy including lenalidomide).
Common side effects associated with Blenrep include reduced visual acuity, corneal abnormalities (including keratopathy), and thrombocytopenia. Othre reported issues include blurred vision, dry eye, foreign-body sensation, eye pain, photophobia, eye irritation, neutropenia, anemia, and diarrhea.
Prior to the first four Blenrep doses, and periodically thereafter, patients should undergo ophthalmic exams, including visual acuity and slit-lamp examination. patients should also promptly report any ocular symptoms to their physicians.
The drug will be available as a powder for concentrate for solution for infusion in 70 mg or 100 mg vials. It is administered as a 30-minute infusion every three or four weeks. Prescribing should be limited to physicians experienced in multiple myeloma treatment.
What’s next
Detailed recommendations will be available in the Summary of Product Characteristics (SmPC) on the EMA website in all official European union languages following marketing authorization by the European Commission. This will further clarify Blenrep’s role in multiple myeloma treatment and management of potential side effects.