Myeloma Treatment Elotuzumab Receives Breakthrough Designation
The FDA has granted breakthrough designation to Bristol-Myers Squibb’s experimental drug elotuzumab, to be used as part of a combo therapy with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more previous therapies, the firm said.
The company is partnering with Abbott spinoff AbbVie on the drug, which currently is in Phase III trials.
Elotuzumab is an anti-CS1 antibody. It binds to the CS1 glycoprotein found on myeloma cells and “Natural Killer” cells, and kills the cancerous cells while leaving healthy cells alone, the company said.
Bristol-Myers Squibb and AbbVie said the designation is based on results from a randomized Phase II, open-label study conducted last year. Results showed that a 10 mg dose of elotuzumab in combination with lenalidomide and low-dose dexamethasone, registered a median progression-free survival rate of 33 months. The Phase III study is using the same dosage, the companies said.
This combo drug is now the second potential new myeloma treatment that has received the breakthrough therapy designation. Genmab and Janssen’s daratumumab received the designation last year.
The breakthrough therapy designation became law in 2012. The new designation was created to accelerate the development and review process for drugs intended to treat serious or life-threatening illnesses.
The FDA’s designation for elotuzumab comes on the heels of their decision to grant elite status for Bristol-Myers Squibbs anti-PD-1 drug nivolumab. — Kellen Owings
Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.