FDAnews
www.fdanews.com/articles/171294-bms-abbvies-myeloma-drug-lengthens-remission-rates-in-late-stage-study

BMS, AbbVie’s Myeloma Drug Lengthens Remission Rates in Late-Stage Study

May 20, 2015

Adding Bristol-Myers Squibb and AbbVie’s immune-based cancer drug elotuzumab to standard therapy extends remission rates for multiple myeloma patients by about four and a half months, compared with standard care alone, data from a late-stage study shows.

Elotuzumab is used in combination with lenalidomide and dexamethasone — the current standard of care for the blood cancer.

The drug received breakthrough designation from the FDA in May 2014.

The Phase III study involved 646 patients with recurring multiple myeloma who had received one or more previous therapies.

Those who received the three-drug combination on average went 19.4 months before their cancer began to worsen, compared with 14.9 months for patients who received just lenalidomide and dexamethasone.

Elotuzumab is an anti-CS1 antibody that binds to a protein on myeloma cells, killing the diseased cells while leaving healthy cells alone. The drug is part of a growing group of cancer treatments that trigger the body’s immune system to fight tumors.

A BMS spokeswoman saidthat it’s premature to discuss plans for seeking regulatory approval for the drug. — Kellen Owings