FDA approves Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone for multiple myeloma- BMS/Abbvie

The FDA has granted approval for Empliciti (elotuzumab), from BMS/Abbvie, in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. It is approved in combination with another FDA-approved treatment for multiple myeloma called Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid).

The safety and efficacy of elotuzumab were tested in a randomized, open-label clinical study of 646 participants whose multiple myeloma came back after, or did not respond to previous treatment. Those taking elotuzumab plus lenalidomide and dexamethasone experienced a delay in the amount of time before their disease worsened (19.4 months) compared to participants taking only lenalidomide and dexamethasone (14.9 months). Additionally, 78.5% of those taking elotuzumab with lenalidomide and dexamethasone saw a complete or partial shrinkage of their tumours compared to 60.1% in those only taking lenalidomide and dexamethasone.

The most common side effects of elotuzumab are fatigue, diarrhoea, fever (pyrexia), constipation, cough, nerve damage resulting in weakness or numbness in the hands and feet (peripheral neuropathy), infection of the nose and throat (nasopharyngitis), upper respiratory tract infection, decreased appetite and pneumonia.

Comment: Darzalex (daratumumab) from Janssen Biotech, approved earlier this month, is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma.

Comment: Other recently approved drugs for multiple myeloma are Pomalyst (pomalidomide) from Celgene and Darzalex (daratumumab) from Janssen Biotech.The potential market leader may be Kyprolis (carfilzomib) from Amgen.