Elotuzumab (Empliciti) gets FDA approval for myeloma30 Nov 2015
The FDA has approved Elotuzumab (Empliciti), Bristol-Myers Squibb’s monoclonal antibody for treatment of relapsed or refractory multiple myeloma. The approval calls for use of elotuzumab in combination with lenalidomide (Revlimid) and dexamethasone in patients who have received one to three prior regimens for myeloma. The drug targets the plasma-cell surface protein SLAMF7.
Positive results in a phase 3 study
The approval was based on data of a phase 3 randomized trial showing a 4.5-month improvement in progression-free survival. The pivotal trial of elotuzumab involved 646 patients with myeloma that had relapsed or proven refractory to the most recent therapy. All patients received lenalidomide and dexamethasone and were randomized to elotuzumab or placebo and followed until disease progression or recurrence.
Data analysis showed:
- A median progression-free survival of 19.4 months with elotuzumab and 14.9 months with placebo.
- Almost 80% of patients in the elotuzumab group had partial or better response as compared with 60% of patients randomized to placebo.
“The two drugs are potentially complementary”
The most commonly reported side effects of treatment with elotuzumab are fatigue, diarrhea, fever, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.
The FDA approval of elotuzumab followed the agency's granting of orphan drug, priority review, and breakthrough-therapy status for the anti-SLAMF7 antibody.
A principal investigator in the elotuzumab pivotal trial, Sagar Lonial, MD, of Emory University's Winship Cancer Institute in Atlanta said the different targets of elotuzumab and daratumumab (CD38) make them potentially complementary, and myeloma clinical researchers have a keen interest in determining whether using the agents in combination is feasible and desirable. Elotuzumab is marketed by Bristol-Myers Squibb.
It's the fourth new FDA approval overall for multiple myeloma this year, joining the oral proteasome inhibitor ixazomib (Ninlaro) and the histone deacetylase inhibitor panobinostat (Farydak), as well as daratumumab.Source: MedPage Today