Blenrep Gets European Nod to Treat Multiple Myeloma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for Blenrep (belantamab mafodotin) for the treatment of relapsed or refractory multiple myeloma. 

The drug is an antibody drug conjugate comprising a humanized IgG1κ monoclonal antibody targeting the B-cell maturation antigen (BCMA), conjugated with a cytotoxic agent, maleimidocaproyl monomethylauristatin F (mcMMAF). Belantamab mafodotin binds to BCMA on the surface of myeloma cells, causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity. According to the manufacturer, GSK, it is the first such conjugate to be approved and represents a new mechanism of action compared with existing agents.

Generally Poor Prognosis

Multiple myeloma is a rare and incurable disease of the plasma cells, typically affecting adults older than 60 years of age. First-line therapy is usually with targeted cancer drugs such as lenalidomide or bortezomib in combination with a steroid, sometimes with chemotherapy and a stem cell transplant. Relapses are treated similarly. The disease has a generally poor prognosis and there is a need for novel effective therapies. Blenrep had been designated as an orphan medicine, and the EMA will now review the information to determine whether this can be maintained.

CHMP said that two phase 3, randomized, open-label studies had shown that adding Blenrep to standard therapy of either bortezomib and dexamethasone in patients who have received at least one prior therapy, or pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide, prolonged progression-free survival in patients with relapsed or refractory multiple myeloma. 

Ocular Side Effects Common

The safety and tolerability profiles of the Blenrep combinations were broadly consistent with those of the individual agents. The most common side effects with Blenrep include reduced visual acuity, corneal examination abnormalities (including keratopathy), thrombocytopenia, blurred vision, dry eye, foreign-body sensation in eyes, eye pain, photophobia, eye irritation, neutropenia, anemia, and diarrhea. 

Patients should have an ophthalmic examination, including visual acuity and slit-lamp examination, by an eye care professional before each of the first four doses of Blenrep, and as clinically indicated thereafter. Patients should be encouraged to inform their physicians of any ocular symptoms.

The drug will be available as 70 mg or 100 mg powder for concentrate for solution for infusion. It is administered as a 30-minute infusion every 3 or 4 weeks. Treatment should be prescribed by physicians experienced in the treatment of multiple myeloma.

Detailed recommendations will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.