Bristol-Myers Squibb and AbbVie’s new cancer treatment elotuzumab has been given a Breakthrough Therapy Designation by the FDA.
The FDA Grants special Breakthrough Therapy designation to candidates, they believe show potential superiority over existing therapies of treatment for serious or life threatening diseases or conditions.
In the past ten years we have seen significant progress of treatment in multiple myeloma. With Celgene’s Thalomid and Revlimid and Janssen’s Velcade all helping to extend median survival times. The drugs have become ever popular in the use of first line therapy, which is making major revenues for the companies. With Celgene’s and Revlimid expected to make $4.5 billion this year.
Many patients have relapsed and stopped responding to Revlimid and Dexamethasone combination. WIth other treatment options available , BMS and AbbVie hope their drug can enter the market as a treatment for these specific patients.
Elotuzumab new designation is based on a randomised Phase 2, open-label study that evaluated two dose levels of the drug in combination with Revlimid and low-dose dexamethasone in previously-treated patients, including the 10 mg/kg dose that is being studied in Phase 3 trials.
Bristol-Myers Squibb have said, despite recent advances in this area of treatment for relapsed or refractory multiple myeloma, it is still an area of unmet need. The Breakthrough Therapy Designation supported the potential of Elotuzumab and further reinforced BMS’s commitment to the disease area.
Elotuzumab is a humanised IgG1 monoclonal antibody targeted against Signalling Lymphocyte Activation Molecule. SLAMF7 is a glycoprotein expressed on myeloma and Natural Killer cells but isn’t detectable in normal tissue. The companies are trying to figure out whether through both direct activation and engagement of Natural Killer cells, Elotuzumab may specifically target and kill SLAMF7 expressing myeloma cells
AbbVie and BMS have collaborated in developing the drug, with BMS leading the commercialisation of the product.